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Find Breast Cancer Clinical Trials That Are Right For You

The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.

Use the search box and filters to find a trial that’s right for you.

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(Last updated: July 25, 2024)

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NEAREST SITE: 3 miles
Zuckerberg San Francisco General
San Francisco,CA

VISITS: 8 visits within 3 months

PHASE: NA

NCT ID: NCT06055803

HEART-ACT Program to Improve Heart Health After Breast Cancer Treatment

The Heart Health After Cancer Treatment (HEART-ACT): A Pilot Study of a Multi-disciplinary Health Behavior Intervention in People With a History of Breast Cancer to Reduce Heart Disease Risk After Cancer Treatment. Scientific Title

Purpose

To study the ability of HEART-ACT, a health behavior program, to reduce heart disease risk after breast cancer treatment.

Who is this for?

People who have stage I, stage II, or stage III breast cancer who have completed treatment. You must have received care at Zuckerberg San Francisco General Hospital. Full eligibility criteria

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You will receive the following as part of the HEART-ACT program: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Visit to create individualized plan and goals</li> <li class="seamTextUnorderedListItem">Health behavior sessions, 3 months</li> <li class="seamTextUnorderedListItem">Exercise program, 3 months</li> <li class="seamTextUnorderedListItem">Fitness tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">The HEART-ACT program covers physical activity, nutrition, emotional well-being, cardiovascular risk, survivorship, and personalized topics such as stopping smoking.</li> <li class="seamTextUnorderedListItem">The program will alternate each week between group and individual sessions and in-person and virtual sessions.</li> <li class="seamTextUnorderedListItem">Individual sessions will be led by a health promotion specialist (nurse or exercise physiologist). These sessions include reviewing goals and making a plan for the next 2 weeks.</li> <li class="seamTextUnorderedListItem">Participants will exercise as part of individual and group sessions. Participants will also be asked to exercise on their own, with a goal of working up to 2.5 hours each week of exercise and 2 strength training sessions.</li> <li class="seamTextUnorderedListItem">At the end of the program, there will be a graduation session to honor the participant's achievement and establish a plan for maintenance after the program.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish and Cantonese.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06055803' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://heartact.ucsf.edu/' target='_blank'>University of California San Francisco: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/breast-cancer/heart-health-breast-cancer-treatment' target='_blank'>WebMD: Heart Health After Breast Cancer Treatment</a> </li></ul>

NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
San Francisco,CA

VISITS: 1 visit every 3 months for 1.5 years

PHASE: NA

NCT ID: NCT05568472

Monitoring Symptoms to Help Women Continue Taking Hormone Therapy for Stage I-III Breast Cancer

A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone to Improve Persistence With Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN) Scientific Title

Purpose

To study if reporting symptoms by email, text, or phone helps women continue taking hormone therapy.

Who is this for?

Premenopausal or perimenopausal women with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who are receiving or planning to receive hormone therapy. You must have received surgery within 2 weeks of beginning this trial. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Receive health education materials</li> <li class="seamTextUnorderedListItem">Attend clinic visits, every 3 months for 1.5 years</li> <li class="seamTextUnorderedListItem">Report symptoms, by email, text, or phone, weekly for 6 months, then monthly for 1 year</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Receive health education materials</li> <li class="seamTextUnorderedListItem">Attend clinic visits, every 3 months for 1.5 years</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy is a common treatment for hormone receptor positive (HR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Hormone therapy can cause side effects which may cause some women to stop treatment early. Asking about symptoms may help women continue taking hormone therapy.</li> <li class="seamTextUnorderedListItem">Health education materials contain information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health.</li> <li class="seamTextUnorderedListItem">Questionnaires can be completed in English or Spanish.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05568472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20070906b' target='_blank'>Breastcancer.org: Side Effects of Hormone Therapy</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Coincides with surgery

PHASE: II

NCT ID: NCT05020574

Impact of Antibiotics on Infection and the Microbiome in People Receiving a Mastectomy

Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction Scientific Title

Purpose

To study the effects (good and bad) of antibiotics after mastectomy with immediate reconstruction on infection and the microbiome.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or some stage III breast cancer or people at risk of breast cancer who are planning to receive a mastectomy with immediate reconstruction. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cephalexin (Keflex®) antibiotic, before and during surgery</li> <li class="seamTextUnorderedListItem">Cephalexin (Keflex®) antibiotic, daily for at least 7 days after surgery</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cephalexin (Keflex®) antibiotic, before and during surgery</li> <li class="seamTextUnorderedListItem">No antibiotics after surgery (unless infection occurs)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A mastectomy is surgery to remove a breast.</li> <li class="seamTextUnorderedListItem">Women with a strong family history of breast cancer or a BRCA mutation may choose to undergo a mastectomy to reduce their risk of developing breast cancer.</li> <li class="seamTextUnorderedListItem">Cephalexin (Keflex®) is an antibiotic used to prevent infection after surgery.</li> <li class="seamTextUnorderedListItem">The microbiome consists of the many bacteria, viruses, and fungi found on your body.</li> <li class="seamTextUnorderedListItem">The harmful bacteria cause disease such as infection, and the beneficial bacteria help keep you healthy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05020574' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/surgery/mastectomy' target='_blank'>Breastcancer.org: Mastectomy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a682733.html' target='_blank'>MedlinePlus: Cephalexin (Keflex®)</a> </li></ul>

NEAREST SITE: 22 miles
Contra Costa Regional Medical Center
Martinez,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03418961

Carvedilol to Prevent Heart Problems in People with Metastatic HER2+ Breast Cancer

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase III Scientific Title

Purpose

To investigate whether a beta-blocker can help prevent heart problems caused by cancer treatments.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who are receiving or planning to receive trastuzumab (Herceptin®). Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Intervention <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol, by mouth, daily for up to 2 years</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No intervention</li> </ul> Group 3: If you are already taking taking a beta blocker, ARB, or ACE inhibitor <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Observation for up to 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity. </li> <li class="seamTextUnorderedListItem">The beta-blocker being used in this study is carvedilol. It is used to treat heart failure and high blood pressure.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03418961' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/side_effects/heart_probs' target='_blank'>Breastcancer.org: Heart Problems</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.health.harvard.edu/heart-health/treatments-for-breast-cancer-may-harm-the-heart' target='_blank'>Harvard Health Publishing: Treatments for Breast Cancer</a> </li></ul>

NEAREST SITE: 336 miles
University of California at Los Angeles
Los Angeles,CA

VISITS: 1 visit

PHASE: NA

NCT ID: NCT04297020

Studying the Effects of Anti-Estrogen Therapy on the Brain of Women with Stage I-III Breast Cancer

Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy Scientific Title

Purpose

To see if anti-estrogen therapy affects brain health.

Who is this for?

Women between the ages of 35 and 65 who are currently taking anti-estrogen therapy for stage I, stage II, or stage III breast cancer and who did not receive chemotherapy. This trial is also enrolling women who have never been diagnosed with breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 Brain fMRI (functional MRI)</li> <li class="seamTextUnorderedListItem">Cognitive testing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial will use an advanced brain MRI technique called functional MRI (fMRI).</li> <li class="seamTextUnorderedListItem">fMRI measures changes in blood flow that happen during mental activity. </li> <li class="seamTextUnorderedListItem">Research suggests that the cognitive issues experienced by some women who receive treatment for breast cancer--also called <q>chemo brain</q>--may actually be caused by anti-estrogen therapy and not chemotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04297020' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/viewarticle/932091' target='_blank'>MedScape: In Breast Cancer, Is Chemobrain Really Endocrine Brain?</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Functional_magnetic_resonance_imaging' target='_blank'>Wikipedia: Functional MRI</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologyinfo.org/en/info.cfm?pg=fmribrain' target='_blank'>RadiologyInfo.org: fMRI</a> </li></ul>

NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05595499

Fisetin to Improve Physical Function in Older Women After Chemotherapy

A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Frail Older Breast Cancer Survivors Scientific Title

Purpose

To study whether fisetin improves physical function in older women after treatment with chemotherapy.

Who is this for?

Women who were at least 65 years old and postmenopausal when diagnosed with stage I, stage II, or stage III breast cancer. You must have completed chemotherapy within the last year. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fisetin, by mouth, 2 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for fisetin, by mouth, 2 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Walking test</li> <li class="seamTextUnorderedListItem">Grip strength test</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fisetin is a naturally occurring substance that is found in strawberries and other foods.</li> <li class="seamTextUnorderedListItem">Fisetin eliminates cells that have stopped dividing but have not died.</li> <li class="seamTextUnorderedListItem">Chemotherapy causes a build-up of these cells which may cause inflammation. damage nearby healthy cells, and cause reduced physical function.</li> <li class="seamTextUnorderedListItem">Improving physical function is also called improving frailty.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05595499' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://restorativemedicine.org/digest/fisetin-powerful-polyphenol-supports-healthy-aging/' target='_blank'>Association for the Advancement of Restorative Medicine: Fisetin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.urmc.rochester.edu/news/story/frailty-in-cancer-patients-young-and-old-is-linked-to-inflammation' target='_blank'>University of Rochester: Frailty and Breast Cancer</a> </li></ul>

NEAREST SITE: 336 miles
UCLA Ronald Reagan Medical Center
Los Angeles,CA

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT05078398

Choice to Receive Opioid Pain Medication After Surgery

Postoperative Opt-In Narcotics Treatment in Breast Scientific Title

Purpose

To determine if the choice to receive opioid pain medication after surgery reduces the use of opioids without increasing pain or decreasing quality of life.

Who is this for?

People with stage 0 (DCIS), stage I, stage II, or stage III breast cancer who are planning to receive outpatient (no overnight hospital stay) surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Counseling about opioids before and after surgery</li> <li class="seamTextUnorderedListItem">Acetaminophen and/or ibuprofen after surgery, by mouth, 5 times</li> <li class="seamTextUnorderedListItem">Opioid after surgery (if requested)</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hydrocodone opioid after surgery, by mouth, 5 times</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Opioids reduce pain after surgery, but they can be addictive.</li> <li class="seamTextUnorderedListItem">Hydrocodone is an opioid pain medication.</li> <li class="seamTextUnorderedListItem">Acetaminophen or ibuprofen are over the counter (OTC), non-opioid pain medication.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05078398' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/podcast/pain-after-surgery' target='_blank'>Breastcancer.org: Ways to Control Pain After Breast Surgery</a> </li></ul>

NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA

VISITS: 2 visits within 2 months

PHASE: II

NCT ID: NCT04290897

Oxaloacetate to Reduce Side Effects After Treatment in People with DCIS and Stage I-III Breast Cancer

A Phase II Single Arm Trial Evaluating the Safety and Efficacy of Anhydrous Enol-Oxaloacetate on Improving Cognitive Complaints in Breast Cancer Survivors Scientific Title

Purpose

To study the safety and ability of oxaloacetate to reduce brain problems, fatigue, sleep problems, and depression after breast cancer treatment.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or some stage III breast cancer who have completed treatment. You must have been diagnosed no more than 5 years ago. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oxaloacetate, by mouth, daily for 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oxaloacetate is a natural substance found in the body and is available as a nutritional supplement.</li> <li class="seamTextUnorderedListItem">Oxaloacetate may reduce inflammation in the brain that could contribute to brain problems (cognition) after cancer treatments.</li> <li class="seamTextUnorderedListItem">Cognition is your ability to think.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04290897' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/side-effects/memory#:~:text=Cancer%20treatments%20such%20as%20chemotherapy,during%20or%20after%20cancer%20treatment.' target='_blank'>National Cancer Institute: Memory or Concentration Problems and Cancer Treatment</a> </li></ul>

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
West Hollywood,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04722341

Time-Restricted Eating to Reduce Treatment Side Effects for People with Stage II-III Breast Cancer

Time-Restricted Eating and Cancer: Clinical Outcomes, Mechanisms, and Moderators Scientific Title

Purpose

To study the effects (good and bad) and anti-cancer activity of time-restricted eating (TRE) during treatment before surgery.

Who is this for?

People with stage II or stage III breast cancer who are planning to receive chemotherapy before surgery (neoadjuvant). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Time-restricted eating (TRE) schedule, 8 hour daily eating period, 6 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Regular eating schedule, 6 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fasting may protect healthy cells from chemotherapy and radiation side effects.</li> <li class="seamTextUnorderedListItem">Time-restricted eating (TRE) involves eating within a period of 10 hours or less, followed by fasting for at least 14 hours daily.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04722341' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/can-fasting-reduce-recurrence-risk' target='_blank'>Breastcancer.org: Can Fasting 13 Hours or More at Night Reduce Recurrence Risk?</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: 1 visit every day for 5 days, then every 6-12 months for 3 years

PHASE: II

NCT ID: NCT06008158

Accelerated Partial Breast Irradiation After Surgery for Women with DCIS or Stage I ER+, HER2- Breast Cancer

Prospective Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation in Low-Risk, Hormone-Responsive Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of accelerated partial breast irradiation (APBI) after surgery (adjuvant) and the ability of APBI to improve breast appearance.

Who is this for?

Women at least 40 years old with stage 0 (DCIS) or stage I estrogen receptor positive (ER+), HER2 negative (HER2-), node negative breast cancer who have negative margins after a lumpectomy. You must not have received treatment before your lumpectomy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Accelerated partial breast irradiation, daily for 5 days</li> <li class="seamTextUnorderedListItem">Follow-up visits, 10 times over 3 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Accelerated partial breast irradiation (APBI) is a type of radiation therapy that delivers radiation only to the part of the breast with cancer.</li> <li class="seamTextUnorderedListItem">APBI is given in a shorter course of treatment than whole breast radiation therapy, over a few days instead of several weeks, with a lower total dose of radiation.</li> <li class="seamTextUnorderedListItem">A lumpectomy is also called a partial mastectomy.</li> <li class="seamTextUnorderedListItem">Node negative means cancer has not spread to your lymph nodes.</li> <li class="seamTextUnorderedListItem">A margin that does not contain tumor cells is called a negative margin and tells the surgeon that the tumor has been removed. A positive margin contains tumor cells at or near the edge of the tissue removed.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06008158' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.moffitt.org/treatments/radiation-therapy/apbi-accelerated-partial-breast-irradiation/' target='_blank'>Moffitt Cancer Center: Accelerated Partial Breast Irradiation</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05340673

Aquaphor and Miaderm for Radiation Dermatitis

A Randomized Clinical Trial Comparing Supplemental Topical Treatments for Acute Radiation Dermatitis in Breast Cancer Patients Scientific Title

Purpose

To compare the ability of Aquaphor and Miaderm, 2 supplemental topical agents, to treat and prevent radiation dermatitis.

Who is this for?

People with DCIS, stage I, stage II, or stage III breast cancer that are receiving external beam radiation therapy (EBRT) after surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aquaphor, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Miaderm, daily</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation dermatitis is a radiation-induced skin reaction that can cause itching, swelling, pain, and general discomfort.</li> <li class="seamTextUnorderedListItem">Aquaphor and Miaderm are 2 supplemental topical agents commonly recommended and used by people with breast cancer undergoing external beam radiation therapy (EBRT).</li> <li class="seamTextUnorderedListItem">Aquaphor is a commonly available, inexpensive, petrolatum-based multi-purpose ointment designed to protect and sooth extremely dry skin, chapped lips, cracked hands and feet, minor cuts and burns, and many other skin irritations.</li> <li class="seamTextUnorderedListItem">Miaderm is a water-based cream and contains ingredients like calendula, hyaluronate, and aloe vera which may help reduce occurrence and severity of radiation dermatitis.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05340673' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/21995-radiation-burns#:~:text=Radiation%20burn%20or%20radiation%20dermatitis,peel%2C%20itch%20or%20turn%20red.' target='_blank'>Cleveland Clinic: Radiation Dermatitis</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: 5 visits within 6 months

PHASE: II

NCT ID: NCT06042569

Lower Chemotherapy Doses for Older Women with Stage I-III HER2 Negative Breast Cancer

Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY) Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of lower and standard doses of docetaxel (Taxotere®) chemotherapy with cyclophosphamide (Cytoxan®) chemotherapy.

Who is this for?

Women at least 65 years old with stage I, stage II, or stage III HER2 negative (HER2-) breast cancer who are planning to receive chemotherapy with docetaxel (Taxotere®) and cyclophosphamide (Cytoxan®). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lower dose docetaxel (Taxotere®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 3 weeks for 3 months </li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard dose docetaxel (Taxotere®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy drugs, such as cyclophosphamide (Cytoxan®) and docetaxel (Taxotere®), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. </li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and docetaxel (Taxotere®) are not well tolerated at the standard dose and can affect the way older people feel physically and emotionally.</li> <li class="seamTextUnorderedListItem">Giving a lower dose may be an effective treatment option and improve quality of life in older women.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06042569' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxotere' target='_blank'>Breastcancer.org: Docetaxel (Taxotere®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li></ul>

NEAREST SITE: 374 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange,CA

VISITS: 1 visit every week for 4 months

PHASE: II

NCT ID: NCT05751668

GM1 to Reduce or Prevent Nerve Pain During Chemotherapy for Metastatic Breast Cancer

An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy Scientific Title

Purpose

To study the ability of GM1 to reduce or prevent nerve pain during treatment with paclitaxel (Taxol®) chemotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer who are planning to receive treatment with paclitaxel (Taxol®) chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GM1, by IV, weekly for 4 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 4 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for GM1, by IV, weekly for 4 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 4 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neuropathy is nerve pain in your hands and feet as a side effect of cancer treatment such as chemotherapy.</li> <li class="seamTextUnorderedListItem">GM1 is a part of the body's natural system that protects nerves from damage.</li> <li class="seamTextUnorderedListItem">Chemotherapy drugs, such as paclitaxel (Taxol®), work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or stopping them from spreading.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05751668' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>

NEAREST SITE: 386 miles
Loma Linda University Cancer Center
Loma Linda,CA

VISITS: 1-2 visits within 1-2 days

PHASE: III

NCT ID: NCT03598426

3 Regimens to Prevent Allergic Reactions to Chemotherapy for Women with Stage I-IV Breast Cancer

Conventional Prophylactic Regimen of Oral Dexamethasone Versus Short-course Intravenous Dexamethasone in Preventing Paclitaxel-related Hypersensitivity Reactions in Breast and Gynecologic Oncology Patients: A Prospective, Randomized, Open-label Study Scientific Title

Purpose

To compare the ability of 3 regimens of dexamethasone, diphenhydramine (Benadryl®), and famotidine to prevent allergic reactions to paclitaxel (Taxol®) chemotherapy.

Who is this for?

Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive paclitaxel (Taxol®). Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone, by mouth</li> </ul> followed 1 day later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Diphenhydramine (Benadryl®), by IV</li> <li class="seamTextUnorderedListItem">Famotidine, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone, by IV</li> <li class="seamTextUnorderedListItem">Diphenhydramine (Benadryl®), by IV</li> <li class="seamTextUnorderedListItem">Famotidine, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone, by mouth</li> </ul> followed 1 day later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone, by IV</li> <li class="seamTextUnorderedListItem">Diphenhydramine (Benadryl®), by IV</li> <li class="seamTextUnorderedListItem">Famotidine, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Dexamethasone, diphenhydramine (Benadryl®), and famotidine are drugs that help prevent allergic reactions to chemotherapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03598426' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a687011.html' target='_blank'>MedlinePlus: Famotidine</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a682792.html' target='_blank'>MedlinePlus: Dexamethasone</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a682539.html' target='_blank'>MedlinePlus: Diphenhydramine (Benadryl®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/side_effects/allergic' target='_blank'>Breastcancer.org: Allergic Reactions</a> </li></ul>

NEAREST SITE: 446 miles
Scripps- MD Anderson Cancer
San Diego,CA

VISITS: 5 visits per week for 3 or 5 weeks

PHASE: II

NCT ID: NCT02912312

The Risk of Developing Lymphedema When Using Hypofractionated Radiation For DCIS & Stage I-III Breast Cancer

Shortening Adjuvant Photon Irradiation to Reduce Edema (SAPHIRE): A Randomized Trial of Hypofractionated Versus Conventionally Fractionated Regional Nodal Irradiation for Invasive Breast Cancer Scientific Title

Purpose

To compare the effects (good and bad) and the risk of developing lymphedema when using hypofractionated radiation therapy of the lymph nodes to traditional radiation therapy of the lymph nodes.

Who is this for?

Women with DCIS or stage I, stage II, or stage III breast cancer. You must have had surgery as part of your treatment unless you had DCIS. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Shorter radiation schedule (hypofractionated) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">15 radiation treatments: 5 days a week, for 3 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires, blood draws, and arm measurements, 7 visits over 10.5 years</li> </ul> Group 2: Standard radiation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">25 radiation treatments: 5 days a week, for 5 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires, blood draws, and arm measurements, 7 visits over 10.5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lymphedema is abnormal swelling in the arm, hand, breast, or torso that develops as a side effect of breast cancer treatments like surgery and radiation therapy. </li> <li class="seamTextUnorderedListItem">Giving the traditional amount of radiation in a shorter period of time is called hypofractionated whole-breast radiation.</li> <li class="seamTextUnorderedListItem">The hypofractionated radiation therapy used in this trial takes about 4 weeks.</li> <li class="seamTextUnorderedListItem">The tradiational radiation therapy used in this trial takes about 6 weeks.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02912312' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/lymphedema/how/treat_impact' target='_blank'>Breastcancer.org: Impact of Radiation Therapy on Lymphedema Risk</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/research-news/shorter-radiation-better-for-early-stage' target='_blank'>Breastcancer.org: Shorter Radiation for Early Stage Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/lymphedema' target='_blank'>Breastcancer.org: Lymphedema</a> </li></ul>

NEAREST SITE: 447 miles
Moores Cancer Center
San Diego,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04343157

Cognitive-Sparing Stereotactic Radiosurgery for Brain Metastasis

UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of cognitive-sparing stereotactic radiosurgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have at least 1 brain tumor that has not been treated with radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive-sparing stereotactic radiosurgery</li> <li class="seamTextUnorderedListItem">MRI scans, 4 scans within 6 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive tests</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Cognitive-sparing stereotactic radiosurgery is a targeted radiation therapy that avoids the white matter and hippocampus (parts of the brain that control memory, language, attention, and cognition).</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04343157' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 517 miles
Saint Alphonsus Regional Medical Center
Boise,ID

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03937154

Romiplostim for Low Blood Platelets During Chemotherapy in People with Breast Cancer

A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of romiplostim (Nplate®) for chemotherapy-induced thrombocytopenia.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving or planning to receive chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Romiplostim (Nplate®), by injection, 3-6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for romiplostim (Nplate®), by injection, 3-6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy-induced thrombocytopenia (CIT) is having a low number of blood platelets, which are blood cells that help your blood clot, as a side effect of chemotherapy.</li> <li class="seamTextUnorderedListItem">Romiplostim (Nplate®) increases the number of blood platelets to help your blood clot and reduce your risk of bleeding.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03937154' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a609008.html' target='_blank'>MedlinePlus: Romiplostim (Nplate®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/diseases-conditions/thrombocytopenia/symptoms-causes/syc-20378293#:~:text=Thrombocytopenia%20is%20a%20condition%20in,plugs%20in%20blood%20vessel%20injuries.' target='_blank'>Mayo Clinic: Thrombocytopenia</a> </li></ul>

NEAREST SITE: 533 miles
OHSU Knight Cancer Institute
Portland,OR

VISITS: At least 4 visits within 1 year

PHASE: NA

NCT ID: NCT04993313

Verbal Counseling and Photo Guide to Reduce Stress from Radiation Therapy for Stage 0-III Breast Cancer

A Randomized Trial of Standard Verbal Counseling With or Without a Pictorial Educational Tool to Reduce Psychological Morbidity in Women Receiving Breast Radiation Therapy Scientific Title

Purpose

To study how effective photos are in reducing stress, anxiety, and depression associated with radiation therapy.

Who is this for?

People with stage 0 (DCIS), stage I, stage II, or some stage III breast cancer who are planning to receive radiation after surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Complete verbal counseling</li> <li class="seamTextUnorderedListItem">View a photo guide</li> <li class="seamTextUnorderedListItem">Questionnaires, 4 times</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Complete verbal counseling</li> <li class="seamTextUnorderedListItem">Questionnaires, 4 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Starting radiation therapy for breast cancer can be stressful. </li> <li class="seamTextUnorderedListItem">Education about what to expect may reduce stress, anxiety, and depression in people starting radiation therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04993313' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation</a> </li></ul>

NEAREST SITE: 602 miles
Huntsman Cancer Institute at the University of Utah
Salt Lake City,UT

VISITS: 2 visits in 1 month

PHASE: NA

NCT ID: NCT05821244

Exercise During Chemotherapy for Women with Stage I-III Breast Cancer

Feasibility of Manipulating Exercise Timing in Breast Cancer Survivors on Chemotherapy Scientific Title

Purpose

To compare the effects of exercise in the morning and evening during chemotherapy.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who are planning to start or have recently started chemotherapy (up to 1 cycle). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Morning Exercise <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Virtual exercise program between 5-10am, 2 times every week for 1 month</li> <li class="seamTextUnorderedListItem">Aerobic exercise, 1.5 hours every week for 1 month</li> <li class="seamTextUnorderedListItem">Physical tests, 2 times</li> <li class="seamTextUnorderedListItem">Exercise logs</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Evening Exercise <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Virtual exercise program between 3-8am, 2 times every week for 1 month</li> <li class="seamTextUnorderedListItem">Aerobic exercise, 1.5 hours every week for 1 month</li> <li class="seamTextUnorderedListItem">Physical tests, 2 times</li> <li class="seamTextUnorderedListItem">Exercise logs</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The exercise sessions will be virtually supervised by a Cancer Exercise Specialist via telehealth.</li> <li class="seamTextUnorderedListItem">Aerobic exercise refers to cardiovascular exercise, which includes activities such as walking, running, biking, and swimming.</li> <li class="seamTextUnorderedListItem">You may choose the type and location of aerobic exercise.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05821244' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/exercise' target='_blank'>Breastcancer.org: Exercise</a> </li></ul>

NEAREST SITE: 602 miles
Huntsman Cancer Institute
Salt Lake City,UT

VISITS: Coincides with radiation sessions, for 2 months

PHASE: NA

NCT ID: NCT06165653

Guided Meditation During Radiation for People with Brain Metastases

An Interventional Trial Using Guided Meditation During Radiation Therapy for Brain Tumors (Med-RT) Scientific Title

Purpose

To study the ability of guided meditation to decrease anxiety.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive radiation to the brain. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Guided meditation during radiation sessions, 2 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Usual care</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The guided meditation practice involves a series of 5 audio recordings with the following topics: body scan, mindful breathing, mindfulness of discomfort, savoring memories, and loving-kindness.</li> <li class="seamTextUnorderedListItem">Each audio recording is 5 minutes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06165653' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 660 miles
Mayo Clinic in Arizona
Scottsdale,AZ

VISITS: 2 visits

PHASE: NA

NCT ID: NCT05417867

Gut Microbiome and Chemotherapy-Induced Nausea in Women with Stage I-III Breast Cancer

A Pilot Study of the Associations Between Chemotherapy-Induced Nausea in Breast Cancer Patients and Gut Microbiome Composition Profiles Scientific Title

Purpose

To study how changes in bacteria in the gut (microbiome) may be associated with chemotherapy-induced nausea.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who are planning to receive chemotherapy. You must be receiving care at Mayo Clinic Arizona or Mayo Clinic Florida. Full eligibility criteria

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You will complete the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide stool samples, 2 times</li> <li class="seamTextUnorderedListItem">Complete questionnaires, 2 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The microbiome consists of the many bacteria, viruses, and fungi found in the digestive tract. Most of the microbiome consists of bacteria in your digestive system. These bacteria can be beneficial or harmful. The harmful bacteria cause disease, and the beneficial bacteria help keep you healthy.</li> <li class="seamTextUnorderedListItem">Nausea is a common side effect of many types of chemotherapy.</li> <li class="seamTextUnorderedListItem">You will provide stool samples 2 times: 1) When you begin the trial, and 2) 3-5 days after starting chemotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05417867' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hsph.harvard.edu/nutritionsource/microbiome/' target='_blank'>Harvard University: What is the Microbiome?</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/about-us/news-personal-stories/can-gut-bacteria-help-treat-breast-cancer' target='_blank'>Breast Cancer Now: Gut Bacteria and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/nausea' target='_blank'>Breastcancer.org: Nausea</a> </li></ul>

NEAREST SITE: 860 miles
Vail Health Shaw Cancer Center
Edwards,CO

VISITS: 7 visits within 2 years

PHASE: II

NCT ID: NCT05637216

Losartan to Reduce Fibrosis for People with Stage 0-IV Breast Cancer

A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients Scientific Title

Purpose

To study the ability of losartan to decrease fibrosis from radiation.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, stage III, and stage IV (metastatic) breast cancer who have received surgery and are planning to receive radiation. Your breast cancer must not have recurred (came back), and you must not have received radiation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Losartan, by mouth, daily during radiation until 1 year after radiation</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for losartan, by mouth, daily during radiation until 1 year after radiation</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Losartan is an FDA approved blood pressure medication that may also decrease fibrosis.</li> <li class="seamTextUnorderedListItem">Fibrosis is the thickening or scarring of tissue and can be caused by radiation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05637216' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/types/breast-cancer/non-cancerous-breast-conditions/fibrosis-and-simple-cysts-in-the-breast.html#:~:text=Neither%20fibrosis%20nor%20simple%20cysts,is%20found%20on%20a%20biopsy.' target='_blank'>American Cancer Society: Breast Fibrosis</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a695008.html' target='_blank'>Medline Plus: Losartan</a> </li></ul>

NEAREST SITE: 941 miles
University of Colorado Hospital
Aurora,CO

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05138510

Sexual Health in People with DCIS and Stage I-IV Breast Cancer

Sexuality and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment Scientific Title

Purpose

To identify the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have received care at the University of Colorado Hospital since September 2019. Full eligibility criteria

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You will participate the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Virtual focus group</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Providers will lead the virtual focus groups over Zoom.</li> <li class="seamTextUnorderedListItem">Focus group findings will be used to create appropriate educational material that will address the sexual health needs of people with breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05138510' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/sex-intimacy' target='_blank'>Breastcancer.org: Sexual Health During and After Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/metastatic/sexuality' target='_blank'>Breastcancer.org: Sexuality and Metastatic Breast Cancer</a> </li></ul>

NEAREST SITE: 1185 miles
Texas Tech University Health Sciences Center
Lubbock,TX

VISITS: At least 7 visits within 1 year

PHASE: I-II

NCT ID: NCT03934905

Sulforaphane Nutritional Supplement to Reduce Heart Problems from Doxorubicin Chemotherapy

Phase II Trial of Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction (CRI18-026) Scientific Title

Purpose

To study if sulforaphane (Avmacol®) reduces heart problems caused by doxorubicin (Adriamycin®) chemotherapy.

Who is this for?

People with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive doxorubicin (Adriamycin®) chemotherapy. You must not have received radiation to your chest, and if your tumor is HER2-positive, you must not be receiving trastuzumab (Herceptin®). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sulforaphane (Avmacol®), by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood tests, 7 times in 1 year</li> <li class="seamTextUnorderedListItem">Heart function tests, 2 times in 1 year</li> <li class="seamTextUnorderedListItem">PET scan, 3 times in 1 year</li> </ul> Group 2: Placebo <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for sulforaphane (Avmacol®), by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood tests, 7 times in 1 year</li> <li class="seamTextUnorderedListItem">Heart function tests, 2 times in 1 year</li> <li class="seamTextUnorderedListItem">PET scan, 3 times in 1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®) is a chemotherapy commonly used to treat breast cancer. It can cause injury to the heart in about 10-20% of patients.</li> <li class="seamTextUnorderedListItem">There is a need to develop new strategies that prevent the harmful effects of doxorubicin (Adriamycin®) but maintain its effectiveness as a cancer therapy.</li> <li class="seamTextUnorderedListItem">Sulforaphane (Avmacol®) is an experimental dietary supplement derived from broccoli and other cruciferous vegetables. It may keep normal cells healthy and enhance cancer cell sensitivity to doxorubicin (Adriamycin®).</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03934905' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/adriamycin' target='_blank'>Breastcancer.org: Doxorubicin (Adriamycin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.avmacol.com/' target='_blank'>Nutramax Laboratories: Sulforaphane (Avmacol®)</a> </li></ul>

NEAREST SITE: 1387 miles
Stephenson Cancer Center
Oklahoma City,OK

VISITS: 2 visits within 2 weeks

PHASE: NA

NCT ID: NCT05921253

Vagus Nerve Stimulation for Heart Problems in People with Stage I-IV Breast Cancer

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN) Scientific Title

Purpose

To study if low level vagus nerve stimulation will improve heart function.

Who is this for?

People at least 50 years old with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have received doxorubicin (Adriamycin®) and/or anti-HER2 targeted therapy within the last 3 months. You must also meet at least 1 of the following criteria: previous chest radiation, type 2 diabetes, high blood pressure, current smoker, obesity, and/or certain heart conditions. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Heart function tests, 2 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Low level stimulation to one ear with handheld device, 2 weeks</li> </ul> Group 2: Placebo <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Heart function tests, 2 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Low level stimulation to one ear (at a different location than group 1) with handheld device, 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">These medications include some chemotherapy and anti-HER2 targeted therapy drugs.</li> <li class="seamTextUnorderedListItem">Stimulation of a nerve called the vagus nerve can have beneficial effects on the heart. Part of the vagus nerve is in the ear.</li> <li class="seamTextUnorderedListItem">The vagus nerve stimulation sessions are 1 hour.</li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05921253' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/some-meds-up-heart-risk-in-overweight-women' target='_blank'>Breastcancer.org: Anthracyclines, Anti-HER2 Medications, and Heart Problems</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.parasym.co/about-parasym.html' target='_blank'>Parasym: Vagus Nerve Stimulation</a> </li></ul>

NEAREST SITE: 1455 miles
Sanford Health Worthington
Worthington,MN

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05889988

Studying Nerve Pain from T-DM1 in People with Stage I-IV HER2 Positive Breast Cancer

A Study of the Natural History of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients Scientific Title

Purpose

To study how trastuzumab emtansine (T-DM1, Kadcyla®) causes nerve pain in people with and without previous nerve pain.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) HER2 positive (HER2+) breast cancer who are planning to receive treatment with trastuzumab emtansine (T-DM1, Kadcyla®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neuropathy is nerve pain in your hands and feet as a side effect of cancer treatment. Neuropathy is pain from nerve damage.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An ADC is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells. Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">T-DM1's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called emtansine.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05889988' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine (T-DM1, Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/neuropathy' target='_blank'>Breastcancer.org: Nerve Pain</a> </li></ul>

NEAREST SITE: 1576 miles
HealthPartners Cancer Research Center
Saint Louis Park,MN

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06083038

Blood Sugar Monitoring for People with Metastatic Breast Cancer Receiving Alpelisib

Utilizing Continuous Glucose Monitoring (CGM) to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib Scientific Title

Purpose

To study how alpelisib (Piqray®) affects blood sugar levels.

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation who are planning to receive alpelisib (Piqray®). You must be receiving your cancer care from a HealthPartners oncologist and must not have diabetes. Full eligibility criteria

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You will receive the following during treatment with alpelisib (Piqray®): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abbott FreeStyle Libre 2 system, at least 3.5 months</li> <li class="seamTextUnorderedListItem">High blood sugar prevention and management program</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">High blood sugar is a common side effect of alpelisib (Piqray®).</li> <li class="seamTextUnorderedListItem">The Abbott FreeStyle Libre 2 system is a wearable device that measures your blood sugar every minute.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06083038' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.freestyle.abbott/us-en/products/freestyle-libre-2.html' target='_blank'>Abbott: FreeStyle Libre 2</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: 1 visit within 2 weeks

PHASE: NA

NCT ID: NCT05412953

Tonation Breathing to Reduce Aromatase Inhibitor Joint and Muscle Pain

Tonation Breathing Technique, a Non-Pharmacogenic Method to Ease Aromatase Inhibitor-Induced Musculoskeletal Symptoms - A Pilot Study Scientific Title

Purpose

To evaluate how well tonation breathing techniques eases joint and/or muscle pain during treatment with an aromatase inhibitor.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who have completed treatment at least 1 month ago and are receiving anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®). You must be experiencing joint and/or muscle pain. Full eligibility criteria

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You will complete the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tonation breathing techniques, daily, 2 weeks</li> <li class="seamTextUnorderedListItem">Questionnaire, 2 times in 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tonation breathing involves creating sounds (tones) while breathing.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05412953' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/coping-with-cancer/physical-emotional-and-social-effects-cancer/managing-physical-side-effects/pain/other-ways-manage-pain' target='_blank'>American Society for Clinical Oncology: Ways to Manage Pain</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: Number of visits unavailable, over 2 months

PHASE: NA

NCT ID: NCT06274034

Headband and Meditation for Improving Anxiety and Insomnia for People with Stage I-IV Breast Cancer

Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors Scientific Title

Purpose

To study the ability of the MUSE S headband and MUSE phone app to reduce anxiety and insomnia.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who were diagnosed within the last 10 years. You must be experiencing anxiety and insomnia (sleep problems). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MUSE S headband, nightly for 2 months</li> <li class="seamTextUnorderedListItem">Meditation with MUSE phone app, for at least 5 minutes daily, for 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anxiety and insomnia (sleep problems) are among the most common side effects of breast cancer.</li> <li class="seamTextUnorderedListItem">Meditation is an effective tool to decrease stress and anxiety.</li> <li class="seamTextUnorderedListItem">The MUSE S headband sends EEG signals to your brain to improve fatigue, quality of life, and stress.</li> <li class="seamTextUnorderedListItem">You will be asked to wear the MUSE S headband to bed every night and meditate using the MUSE phone app for at least 5 minutes every day.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06274034' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03879629

Carvedilol to Prevent or Treat Treatment Related Heart Problems for HER2+ Breast Cancer

TrAstuzumab Cardiomyopathy Therapeutic Intervention With Carvedilol (TACTIC) Trial Scientific Title

Purpose

To study if carvedilol (Coreg®), a beta-blocker medication, can prevent or treat heart problems caused by cancer treatments.

Who is this for?

People with stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who are planning to receive treatment with trastuzumab (Herceptin®) or T-DM1 (Kadcyla®). Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Begin Before Targeted Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®), by mouth, daily, until end of anti-HER2 targeted therapy</li> </ul> Group 2: Begin After Early Signs of Heart Problems <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®), by mouth, daily, until end of anti-HER2 targeted therapy</li> </ul> Group 3: Begin After Heart Problems Begin (Standard of Care) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®), by mouth, daily, until end of anti-HER2 targeted therapy</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">After end of anti-HER2 targeted therapy, you will randomly either continue carvedilol (Coreg®) for 1 year or stop carvedilol (Coreg®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®) is a type of medication called a beta-blocker. It is approved to treat people who have high blood pressure or heart failure or who have had a heart attack.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) or T-DM1 (Kadcyla®) are anti-HER2 targeted therapies known to increase the risk of heart problems.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03879629' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/carvedilol-oral-route/description/drg-20067565' target='_blank'>Mayo Clinic: Carvedilol (Coreg®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20111208b' target='_blank'>Breastcancer.org: Heart Problems Caused by Herceptin May Be More Common Than Thought</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05056857

Studying the Effects of Tamoxifen in People with ER+ Breast Cancer

Neutrophil Functions in Breast Cancer Scientific Title

Purpose

To study the long-term effects of tamoxifen (Nolvadex®) on excessive production of neutrophil extracellular traps (NET) and their impact on breast cancer and side effects.

Who is this for?

Pre-menopausal and post-menopausal women with stage I, stage II, stage III, or stage IV (metastatic) estrogen receptor positive (ER+) breast cancer receiving treatment with tamoxifen for at least 6 months. Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neutrophil extracellular traps (NET) are produced by the body to fight infections but have also been linked to side effects caused by the body's immune system.</li> <li class="seamTextUnorderedListItem">Treatment with tamoxifen (Nolvadex®) increases the production of NETs.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05056857' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/drugs/9785-tamoxifen' target='_blank'>Cleveland Clinic: Tamoxifen (Nolvadex®)</a> </li></ul>

NEAREST SITE: 1643 miles
MD Anderson
Houston,TX

VISITS: 1 visit that coincides with surgery

PHASE: NA

NCT ID: NCT04606030

Using a Biobridge Scaffold During Lymphedema Surgery

LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema Scientific Title

Purpose

To investigate the safety and effects (good and bad) of using an experimental device called a Biobridge scaffold during surgery to treat lymphedema.

Who is this for?

People who have completed breast cancer treatment at least three years ago, have no evidence of disease, and have been diagnosed with lymphedema. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vascularized Lymph Node Transplant surgery (VLNT) </li> <li class="seamTextUnorderedListItem">BioBridge Collagen Matrix inserted into your body during surgery </li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vascularized Lymph Node Transplant surgery (VLNT)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lymphedema is abnormal swelling in the arm, hand, breast, or torso that may develop as a side effect of some breast cancer therapies. </li> <li class="seamTextUnorderedListItem">Lymphedema happens when there is a blockage in your lymphatic system (a part of your immune system) that stops the lymph fluid from draining well. The fluid buildup causes the abnormal swelling. </li> <li class="seamTextUnorderedListItem">The surgery used in this trial to help with your lymphedema is called a vascularized lymph node transfer.</li> <li class="seamTextUnorderedListItem">Your doctor will insert a Biobridge scaffold during your vascularized lymph node transfer. </li> <li class="seamTextUnorderedListItem">The Biobridge scaffold is made of collagen and may help lymph vessels grow around lymph blockages.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04606030' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/conditions-and-diseases/breast-cancer/breast-cancer-lymphedema-after-treatment' target='_blank'>Johns Hopkins Medicine: Breast Cancer, Lymphedema After Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://intermountainhealthcare.org/services/cancer-care/treatments-and-procedures/lymphedema-treatment/our-services/vascularized-lymph-node-transfer/' target='_blank'>Intermountain Healthcare: Vascularized Lymph Node Transfer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fibralignbio.com/biobridge-2/' target='_blank'>Fibralign Corporation Medical Device Information Page: Biobridge</a> </li></ul>

NEAREST SITE: 1643 miles
Houston Methodist Cancer Center
Houston,TX

VISITS: 4 visits, over 6 months

PHASE: II

NCT ID: NCT01984138

Hormone Therapy or Lotion Inside the Vagina for Women with Stage I-III ER+ Breast Cancer Taking an Aromatase Inhibitor (Anti-Estrogen Therapy)

REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy Scientific Title

Purpose

To compare the safety and effects of using vaginal estrogen (Estring) or a vaginal moisturizer (Replens) to treat vaginal dryness, pain during intercourse, and other vaginal side effects of taking an aromatase inhibitor.

Who is this for?

Postmenopausal women with stage I, stage II, or stage III estrogen-receptor positive (ER+) breast cancer experiencing vaginal dryness, pain during intercourse, or 3 or more urinary tract infections a year since starting an aromatase inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estring vaginal ring, inserted into the vagina, every 3 months, for 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Replens vaginal lotion, applied inside the vagina, 3 times a week, for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of anti-estrogen therapy commonly used for stage I-IV hormone-positive (ER+ and/or PR+) breast cancer. </li> <li class="seamTextUnorderedListItem">The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">The side effects of taking an aromatase inhibitor may include vaginal dryness, vaginal itching, pain during intercourse, and urinary tract infections. </li> <li class="seamTextUnorderedListItem">Replens is a moisturizer that is applied inside the vagina. It does not contain any hormones.</li> <li class="seamTextUnorderedListItem">Estring is a ring that is placed inside the vagina and releases a low dose of estrogen.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01984138' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.houstonmethodist.org/1285_houstonmethodist/2847_ourresearch/2922_research_clinicaltrials/2923_research_searchclinicaltrials/clinicaltrialdetailnew/?Id=Pro00017710' target='_blank'>Houston Methodist Medical Center: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.estring.com/vaginal-atrophy-relief#estring' target='_blank'>Pfizer Drug Information Page: Estring (Vaginal Estrogen)</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.replens.com/Products/Replens-Long-Lasting-Moisturizer/FAQS.aspx' target='_blank'>Replens Drug Information Page: Replens (Vaginal Moisturizer)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/tips/menopausal/treat/vaginal-changes' target='_blank'>Breastcancer.org: Menopause Symptoms and Vaginal Changes</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05928325

Education and Support Program to Improve the Health of Older Adults with Stage I-III Breast Cancer

Implementation of a Geriatric Care Survivorship Intervention in Older Adults Who Have Completed Curative Intent Therapy for Early-Stage Breast Cancer Scientific Title

Purpose

To study the ability of an education and support survivorship program to improve the overall health of older adults who have completed breast cancer treatment.

Who is this for?

People at least 65 years old with stage I, stage II, or stage III breast cancer who are within 3 months of completing chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Health assessments, 3 times within 1 year</li> <li class="seamTextUnorderedListItem">Education about survivorship</li> <li class="seamTextUnorderedListItem">Wearable device, 1 year</li> <li class="seamTextUnorderedListItem">Supportive therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The health assessment asks about your physical, mental, and emotional health.</li> <li class="seamTextUnorderedListItem">Wearable devices such as FitBits are used to track your physical activity.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05928325' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/breast-cancer-elderly-treating-growing-patient-population/?psafe_param=1&utm_source=google&utm_medium=cpc&gclid=Cj0KCQjwuZGnBhD1ARIsACxbAVgxOj7KCm21Zmg5TCplhMCDhvola-e-h9IoQWD0A-pi9eLpEHWIIfgaAsz1EALw_wcB' target='_blank'>Breast Cancer Research Foundation: Older Adults and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mycarg.org/?page_id=437' target='_blank'>Cancer and Aging Resource Group: Improving the Care of Older Adults with Cancer</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 5 visits within 3 months

PHASE: I

NCT ID: NCT04038619

Fecal Microbiota Transplantation for Immunotherapy-Related Diarrhea or Colitis in People with Stage I-IV Breast Cancer

Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients Scientific Title

Purpose

To study the ability of a fecal microbiota transplantation to improve immune checkpoint inhibitor-related diarrhea and colitis.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who developed diarrhea and/or colitis after receiving treatment with dostarlimab (Jemperli®) or pembrolizumab (Keytruda®) immune checkpoint inhibitors. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Loperamide, by mouth, 1 time</li> </ul> followed 4 hours later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fecal microbiota transplantation during colonoscopy, 1 time</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A fecal microbiota transplantation consists of taking healthy bacteria (microbiota or microbiome) from the feces or stool of a healthy donor and transferring them to the colon of the recipient during a colonoscopy.</li> <li class="seamTextUnorderedListItem">A colonoscopy is a procedure in which a flexible camera is inserted through the anus to examine the colon/intestines.</li> <li class="seamTextUnorderedListItem">Loperamide is a drug used to treat diarrhea.</li> <li class="seamTextUnorderedListItem">Colitis is inflammation of the colon/intestines.</li> <li class="seamTextUnorderedListItem">Your body is home to many bacteria, viruses, and fungi, which are collectively called the microbiome.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04038619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0663.html' target='_blank'>MD Anderson Cancer Center: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/fecal-transplant' target='_blank'>Johns Hopkins Medicine: Fecal Microbiota Transplantation</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a682280.html' target='_blank'>MedlinePlus: Loperamide</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 1678 miles
UW Health Oncology Clinics
Madison,WI

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05609435

REASSURE Follow-Up Care After Treatment for Stage I HR+, HER2- Breast Cancer

Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin Scientific Title

Purpose

To study whether REASSURE follow-up care improves survivors' preparedness for survivorship.

Who is this for?

Women with stage I hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer diagnosed between 6 months and 2 years ago who have completed treatment. You must not have received chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">REASSURE follow-up care</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care follow-up care</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">REASSURE follow-up care is comprised of three components: 1) the REASSURE patient-reported outcome (PRO) questionnaire to assess your symptoms/concerns, 2) a recommendation for or against a follow-up visit based on your symptoms/concerns, and 3) REASSURE survivorship messaging, including reassurance about the low recurrence risk, an overview of what to expect from follow-up, and steps you can take to reduce cancer risk.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05609435' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/cancer-types/breast-cancer/follow-care-and-monitoring#:~:text=Your%20follow%2Dup%20care%20may,treated%20for%20curable%20breast%20cancer.' target='_blank'>ASCO: Breast Cancer Follow-up Care and Monitoring</a> </li></ul>

NEAREST SITE: 1827 miles
Northwestern Memorial HealthCare, Central DuPage Hospital, Warrenville Cancer Center
Winfield,IL

VISITS: 10 visits within 2 weeks

PHASE: I

NCT ID: NCT05417282

MW151 and Hippocampal-Avoidant Whole Brain Radiation Therapy for Brain Metastasis

Safety and Tolerability of MW151 Administered With Hippocampal Avoidant Whole Brain Radiation Therapy (HA-WBRT) in Patients With Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), anti-cancer activity, and cognitive effects of MW151, an experimental drug, with hippocampal-avoidant whole brain radiation therapy.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who have not received whole brain radiation therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MW151, by mouth, daily for 1 month</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hippocampal-avoidant whole brain radiation therapy, 10 days within 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for MW151, by mouth, daily for 1 month</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hippocampal-avoidant whole brain radiation therapy, 10 days within 2 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive tests</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MW151 is an experimental drug that may reduce brain inflammation and improve cognitive function.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) treats the entire brain, even tumors that may be too small to see with an MRI.</li> <li class="seamTextUnorderedListItem">Hippocampal avoidance whole brain radiation therapy (HA-WBRT) is a targeted radiation therapy that avoids the hippocampus (part of the brain that controls learning and memory) during radiation therapy.</li> <li class="seamTextUnorderedListItem">Cognitive tests study your cognition, which is your ability to think.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05417282' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 1832 miles
Medical College of Wisconsin
Milwaukee,WI

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03824145

Every Day Counts Lifestyle Program to Improve Quality of Life for Women with Metastatic Breast Cancer

Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer Scientific Title

Purpose

To study whether the Every Day Counts lifestyle program improves the quality of life of women with metastatic breast cancer.

Who is this for?

Women with metastatic (stage IV) breast cancer that is currently stable and who live in Milwaukee, Wisconsin or Chicago, Illinois. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Every Day Counts lifestyle program, 4 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Home/work organization intervention, 4 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Every Day Counts lifestyle program promotes nutritional and physical activity changes based on the American Cancer Society nutrition and physical activity guidelines.</li> <li class="seamTextUnorderedListItem">The Every Day Counts lifestyle program consists of: 1) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating.</li> <li class="seamTextUnorderedListItem">The home/work organization intervention consists of: 1) a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter, 2) virtual or weekly phone calls with a home organization coach with standard prompts, 3) text messages supporting home/work organization.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03824145' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/healthy/eat-healthy-get-active/acs-guidelines-nutrition-physical-activity-cancer-prevention/guidelines.html' target='_blank'>American Cancer Society: Guideline for Diet and Physical Activity</a> </li></ul>

NEAREST SITE: 1832 miles
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee,WI

VISITS: Daily for 10 days

PHASE: II

NCT ID: NCT05045950

Memantine for Cognition with Whole Brain Radiation Therapy for Brain Metastasis

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases Scientific Title

Purpose

To study the effects (good and bad) of memantine and whole brain radiation therapy (WBRT) on your cognition (ability to think).

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Memantine (Namenda®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) with pulsed reduced dose rate (PRDR), daily for 10 days</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive testing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) is radiation therapy that treats the entire brain.</li> <li class="seamTextUnorderedListItem">WBRT with pulsed reduced dose rate (PRDR) uses a slower rate of radiation to improve safety and anti-cancer activity.</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®) is a medication that treats cognition (ability to think).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05045950' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/drugs/2/drug-77932-377/memantine-oral/memantine-oral/details' target='_blank'>WebMD: Memantine</a> </li></ul>

NEAREST SITE: 1832 miles
Froedtert Hospital
Milwaukee,WI

VISITS: 1 visit

PHASE: II

NCT ID: NCT03571334

Botulinum Toxin A for Nerve Pain Caused by Chemotherapy in People with Breast Cancer

Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy Scientific Title

Purpose

To study the safety and ability of incobotulinumtoxinA (INA) (Xeomin®) to treat chemotherapy induced peripheral neuropathy (CIPN).

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have chemotherapy induced peripheral neuropathy (CIPN). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IncobotulinumtoxinA (INA) (Xeomin®), by injections into hands or feet, 1 time</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saline water, by injections into hands or feet, 1 time</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires, 5 times within 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy induced peripheral neuropathy (CIPN) is nerve pain in your hands and feet as a side effect of chemotherapy.</li> <li class="seamTextUnorderedListItem">Neuropathy is pain from nerve damage.</li> <li class="seamTextUnorderedListItem">IncobotulinumtoxinA (INA) (Xeomin®) may help treat nerve pain by inhibiting parts of the pain signaling pathway.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03571334' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/peripheral-neuropathy/what-is-peripherial-neuropathy.html' target='_blank'>American Cancer Society: Chemotherapy Induced Peripheral Neuropathy (CIPN)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/drugs/2/drug-154593/xeomin-intramuscular/details' target='_blank'>WebMD: IncobotulinumtoxinA (INA) (Xeomin®)</a> </li></ul>

NEAREST SITE: 1853 miles
University of Illinois at Chicago College of Nursing
Chicago,IL

VISITS: 2 visits every week for 1.5 months

PHASE: NA

NCT ID: NCT05417451

Acupuncture for Pain, Fatigue, and Sleep Problems After Treatment for Women with Stage 0-III HR+ Breast Cancer

Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors Scientific Title

Purpose

To study if acupuncture can improve pain, fatigue, and sleep problems and how acupuncture affects biomarkers.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who have completed treatment between 3 months and 5 years ago and are receiving hormone therapy. You must be experiencing at least 2 of the following: pain, fatigue, sleep problems. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Acupuncture, 2 sessions per week for 1.5 months</li> <li class="seamTextUnorderedListItem">Blood samples</li> <li class="seamTextUnorderedListItem">Stool samples</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pain, fatigue, and sleep problems can be side effects of cancer treatment.</li> <li class="seamTextUnorderedListItem">Acupuncture may help ease these problems.</li> <li class="seamTextUnorderedListItem">A biomarker is a gene, molecule, or other feature present in a person that tells doctors something about that person’s health.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05417451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/complementary-therapy/types/acupuncture' target='_blank'>Breastcancer.org: Acupuncture for Pain and Fatigue</a> </li></ul>

NEAREST SITE: 1853 miles
University of Illinois Chicago
Chicago,IL

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05259410

Time Restricted Eating During Chemotherapy for Women with Stage I-III Breast Cancer

The Safety and Efficacy of Time Restricted Eating Combined With Chemotherapy During Breast Cancer Treatment Scientific Title

Purpose

To study whether time restricted eating during chemotherapy improves treatment-related outcomes and quality of life and limits treatment-related side effects and weight gain.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who are planning to receive chemotherapy after surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Time restricted eating, 3 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No time restricted eating, 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Time restricted eating, a form of intermittent fasting, is eating all food within the hours of 10:00am and 6:00pm, with water fasting the remaining hours of the day.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05259410' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/intermittent-fasting-may-help-cancer-treatments-work-better' target='_blank'>Breastcancer.org: Intermittent Fasting May Help Cancer Treatments Work Better</a> </li></ul>

NEAREST SITE: 1854 miles
AMITA Health Saint Joseph Chicago
Chicago,IL

VISITS: Coincides with surgery

PHASE: II

NCT ID: NCT05554211

Tranexamic Acid to Reduce Drainage After Bilateral Mastectomy

Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage Scientific Title

Purpose

To study the safety and ability of tranexamic acid to reduce drainage after a bilateral mastectomy.

Who is this for?

Women who are planning to receive a bilateral mastectomy to reduce their risk of developing breast cancer and women with DCIS, stage I, stage II, or some stage III breast cancer who are planning to receive a bilateral mastectomy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tranexamic acid, by skin</li> <li class="seamTextUnorderedListItem">Gentamicin</li> </ul> Group 2: Standard Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo (saline) for tranexamic acid, by skin</li> <li class="seamTextUnorderedListItem">Gentamicin</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A bilateral mastectomy is surgery to remove both breasts.</li> <li class="seamTextUnorderedListItem">Women with a strong family history of breast cancer or a BRCA mutation may choose to undergo a bilateral mastectomy to reduce their risk of developing breast cancer.</li> <li class="seamTextUnorderedListItem">Drains help remove fluid build up in the area where the breast is removed.</li> <li class="seamTextUnorderedListItem">Tranexamic acid is an FDA approved drug that promotes blood clotting by preventing the breakdown of blood clots that your body naturally forms.</li> <li class="seamTextUnorderedListItem">Tranexamic acid is commonly used to control bleeding in a variety of surgeries and is available in injection or oral forms. However, because it is not currently FDA approved for use in elective breast surgery, this drug is considered experimental in this study. </li> <li class="seamTextUnorderedListItem">Gentamicin is an antibiotic used to prevent infection after surgery.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05554211' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/cancers/breast-cancer/treatment/bilateral-mastectomy/' target='_blank'>Moffitt Cancer Center: Bilateral Mastectomy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612021.html' target='_blank'>Medline Plus: Tranexamic Acid</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/managing-your-surgical-drains-following-breast-surgery-4021630' target='_blank'>Verywell Health: Surgical Drains After Breast Surgery</a> </li></ul>

NEAREST SITE: 1856 miles
Northwestern University
Chicago,IL

VISITS: 3 visits within 1 year

PHASE: I

NCT ID: NCT06081127

Physical Therapy and Education Before Treatment for Women with Stage 0-IV Breast Cancer

A Randomized Pilot Test of the Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Functional Recovery (MOve-ABC) (B-PREPed) Scientific Title

Purpose

To study the ability of the Moving On After Breast Cancer (MOve-ABC) program to provide physical therapy and education before breast cancer treatment.

Who is this for?

Women with newly diagnosed stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have not yet received treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Moving On After Breast Cancer (MOve-ABC) Program <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Education about breast cancer side effects</li> <li class="seamTextUnorderedListItem">Physical therapy evaluation</li> <li class="seamTextUnorderedListItem">Home exercise program</li> <li class="seamTextUnorderedListItem">Phone calls and text messages</li> <li class="seamTextUnorderedListItem">Additional referrals (if needed)</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Education on surgery recovery and pain management</li> <li class="seamTextUnorderedListItem">Additional referrals (if needed)</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physical therapy before cancer treatment aims to help with early identification and self-management of treatment side effects.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06081127' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/exercise' target='_blank'>Breastcancer.org: Exercise and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cedars-sinai.org/health-library/diseases-and-conditions/p/physical-therapy---breast-cancer.html' target='_blank'>Cedars Sinai: Physical Therapy for Breast Cancer</a> </li></ul>

NEAREST SITE: 1857 miles
University of Chicago
Chicago,IL

VISITS: 1 visit

PHASE: NA

NCT ID: NCT03238976

Nature Sounds to Reduce Pain and Anxiety During a Breast Core Needle Biopsy

Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy: A Randomized Study Scientific Title

Purpose

To investigate the effects (good and bad) playing continuous nature sounds during a core needle biopsy has on a patient's pain and anxiety.

Who is this for?

Women scheduled to have a breast core needle biopsy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive continuous nature sounds during core needle biopsy</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive supportive dialogue during core needle biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A core needle biopsy is a procedure that removes a small amount of suspicious tissue from the breast with a needle.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03238976' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/CoreNeedleBiopsy.html' target='_blank'>Susan G. Komen: Core Needle Biopsy</a> </li></ul>

NEAREST SITE: 1933 miles
IU Health West
Avon,IN

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05468034

Exercise for People with Metastatic Breast Cancer

Exercise in Metastatic Breast Cancer: EMBody Scientific Title

Purpose

To study if a virtual exercise program improves fitness, muscle mass, and quality of life.

Who is this for?

People with metastatic (stage IV) breast cancer that has not progressed within the last year or who have no evidence of disease (NED). You must be participating in less than 2.5 hours of exercise per week. You must not have received chemotherapy within the last year. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Virtual exercise program, 3 times per week for 4 months</li> <li class="seamTextUnorderedListItem">Classes on creating and maintaining behavior changes</li> </ul> Group 2: Standard of Care' <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Usual care</li> <li class="seamTextUnorderedListItem">American College of Sports Medicine handouts</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise.</li> <li class="seamTextUnorderedListItem">During sessions, you will wear a provided heart rate monitor with a training goal of moderate intensity.</li> <li class="seamTextUnorderedListItem">Each exercise session is 1 hour.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05468034' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/metastatic/treatment/exercise-tips' target='_blank'>Breastcancer.org: Exercise and MBC</a> </li></ul>

NEAREST SITE: 1959 miles
Center for Cognitive Medicine at Vanderbilt University
Nashville,TN

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05283629

Improving Chemotherapy-Related Cognitive Problems After Treatment in People with Stage I-III Breast Cancer

Neuroplasticity-Based Cognitive Remediation for Chemotherapy Related Cognitive Impairment Randomized Study Scientific Title

Purpose

To study the ability of a type of training called neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).

Who is this for?

People between 35-80 years of age who have been diagnosed with stage 0 (DCIS), stage I, stage II, or stage III breast cancer who have completed treatment. You must have cognitive problems as a result of receiving chemotherapy within the last 1-8 years. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neuroplasticity-based Computerized Cognitive Remediation (nCCR)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Educational DVDs</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neuroplasticity-based Computerized Cognitive Remediation (nCCR) aims to improve processing of sensory stimuli and cognitive control functions.</li> <li class="seamTextUnorderedListItem">Educational DVDs include content on history, art, science, etc. and are comparable to nCCR in length, audio-visual presentation, computer use, and contact with research staff.</li> <li class="seamTextUnorderedListItem">Chemotherapy-related cognitive impairment (CRCI), often referred to as <q>chemo brain</q>, is a common and highly distressful side effect of chemotherapy.</li> <li class="seamTextUnorderedListItem">The most commonly reported CRCI symptoms include problems with executive function, which is involved in planning, problem-solving, organization, and time management.</li> <li class="seamTextUnorderedListItem">The term <q>neuroplasticity</q> refers to the brain's ability to modify, change, and adapt throughout life and in response to experience. Neuroplasticity can be improved through the use of focused brain training in nCCR.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05283629' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/podcast/chemobrain-update' target='_blank'>Breastcancer.org: Chemo Brain Update: Cancer-Related Cognitive Decline</a> </li></ul>

NEAREST SITE: 1984 miles
James Graham Brown Cancer Center
Louisville,KY

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT04990921

Palliative Radiation and Immunotherapy for People with Metastatic Breast Cancer

A Phase 2 Study of Palliative Radiation in Combination With Pembrolizumab in Subjects With Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of stereotactic radiation with pembrolizumab (Keytruda®) immunotherapy.

Who is this for?

Women with stage IV (metastatic) breast cancer who have received at least 2 lines of therapy, including 1 line of chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation, 1-5 sessions</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Palliative radiation reduces side effects of metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04990921' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncolink.org/support/hospice-and-palliative-care/palliative-radiation-treatment#:~:text=Palliative%20radiation%20is%20the%20use,doses)%20than%20traditional%20radiation%20treatment.' target='_blank'>OncoLink: Palliative Radiation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 2010 miles
UAB Spain Rehabilitation Center
Birmingham,AL

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06006299

Vagus Nerve Stimulator for Insomnia in People with Stage I-IV Breast Cancer

Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer Scientific Title

Purpose

To study the ability of vagus nerve stimulation to improve sleep, anxiety, depression, and cancer related fatigue.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have difficulty falling asleep, staying asleep, or waking up too early. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vagus nerve stimulator, daily for 2 weeks</li> <li class="seamTextUnorderedListItem">Fitbit</li> <li class="seamTextUnorderedListItem">Sleep diary</li> <li class="seamTextUnorderedListItem">Surveys</li> <li class="seamTextUnorderedListItem">Interviews</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vagus nerve stimulation delivers low-intensity electrical currents in the inner ear to stimulate nerves that may improve sleep.</li> <li class="seamTextUnorderedListItem">Insomnia is difficulty falling asleep, staying asleep, or waking up too early.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06006299' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/vagus-nerve-stimulation/about/pac-20384565' target='_blank'>Mayo Clinic: Vagus Nerve Stimulation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/insomnia#:~:text=Advertisement-,Insomnia%20can%20be%20caused%20by%20the%20stress%20of%20a%20breast,get%20a%20good%20night's%20sleep.' target='_blank'>Breastcancer.org: Insomnia and Breast Cancer</a> </li></ul>

NEAREST SITE: 2013 miles
The University of Alabama at Birmingham
Birmingham,AL

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06133348

PRISM Sessions to Reduce Stress for Women with Stage I-IV Breast Cancer

Promoting Resilience in Women With Breast Cancer (PRISM) Scientific Title

Purpose

To study the ability of Promoting Resilience in Stress Management (PRISM) sessions to reduce stress.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who are receiving neoadjuvant (before surgery) chemotherapy, and women with stage IV (metastatic) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRISM sessions</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Promoting Resilience in Stress Management (PRISM) sessions are led by coaches.</li> <li class="seamTextUnorderedListItem">Session topics include goal-setting, and positive reframing.</li> <li class="seamTextUnorderedListItem">Previous studies found that PRISM sessions can improve resilience, psychological distress, hope, and quality of life.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06133348' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2013 miles
University of Alabama at Birmingham
Birmingham,AL

VISITS: 3 visits per week for 2.5 months

PHASE: NA

NCT ID: NCT04088708

Impact of Exercise on Gut Microbiome and Fatigue After Treatment

Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study) Scientific Title

Purpose

To study if exercise changes the gut microbiome and fatigue levels.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or stage III breast cancer who have completed treatment at least 1 year ago and are experiencing fatigue. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aerobic exercise sessions with an instructor, 20-60 minutes, 3 times a week, 10 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Flexibility/toning exercise sessions with an instructor, 40 minutes, 3 times a week, 10 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires, 4 times</li> <li class="seamTextUnorderedListItem">Wearable device</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cancer survivors are at increased risk of gut bacteria communities (microbiome) that can negatively impact health and energy levels.</li> <li class="seamTextUnorderedListItem">Exercise may cause healthy changes in the gut microbiome.</li> <li class="seamTextUnorderedListItem">Fatigue (severe tiredness) is a common long-term side effect of breast cancer treatment.</li> <li class="seamTextUnorderedListItem">Aerobic exercise refers to cardiovascular exercise, which includes activities such as walking, running, biking, and swimming.</li> <li class="seamTextUnorderedListItem">Flexibility/toning activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, and ankle/foot.</li> <li class="seamTextUnorderedListItem">Wearable devices are used to track your physical activity outside of exercise sessions.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04088708' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/for-patients-and-families/for-survivors/caring-for-yourself-after-cancer/your-body-after-treatment/' target='_blank'>Dana-Farber Cancer Institute: Your Body After Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.e22178' target='_blank'>ASCO Abstract: Gut Microbiome Alterations in Breast Cancer Survivors with Cancer-Related Fatigue</a> </li></ul>

NEAREST SITE: 2039 miles
University of Cincinnati
Cincinnati,OH

VISITS: 3 visits within 2 months

PHASE: NA

NCT ID: NCT05868187

Exercise and Education for Fatigue After Breast Cancer Treatment

CanRestoreFunction: Cancer-Related Fatigue Management Scientific Title

Purpose

To determine if an online cancer related fatigue (CRF) management intervention will reduce cancer related fatigue, improve quality of life, and improve ability to think.

Who is this for?

People with stage I, stage II, or stage III breast cancer who are within 5 years of diagnosis and received chemotherapy and/or radiation. You must be experiencing fatigue. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized exercise program, 3 times every week for 2 months</li> <li class="seamTextUnorderedListItem">Goal setting, weekly for 2 months</li> <li class="seamTextUnorderedListItem">Educational modules, 4 sessions</li> <li class="seamTextUnorderedListItem">Physical function tests, 3 sessions</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Normal daily routine</li> <li class="seamTextUnorderedListItem">Physical function tests, 3 sessions</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Treatments for cancer can cause fatigue, which is tiredness that does not improve with sleep.</li> <li class="seamTextUnorderedListItem">Cognition is your ability to think.</li> <li class="seamTextUnorderedListItem">Exercise and other activities may reduce fatigue.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05868187' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/fatigue' target='_blank'>Breastcancer.org: Fatigue from Cancer</a> </li></ul>

NEAREST SITE: 2054 miles
University of Michigan Comprehensive Cancer Center
Ann Arbor,MI

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06228768

Acupressure for Joint and Muscle Pain for People with Stage I-IV Breast Cancer

Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer Scientific Title

Purpose

To study the ability of acupressure to reduce joint and muscle pain and the impact of acupressure on the gut microbiome.

Who is this for?

Postmenopausal women and men with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving an aromatase inhibitor. You must be experiencing joint or muscle pain. Full eligibility criteria

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You will receive the following <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Acupressure, 3 months</li> <li class="seamTextUnorderedListItem">Stool samples</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Acupressure is similar to acupuncture, but uses pressure rather than needles to target specific points on the body.</li> <li class="seamTextUnorderedListItem">Acupressure involves applying mild to moderate pressure using your fingers, or a device, to these points to try to bring a change in your body, such as reduce joint pain and stiffness.</li> <li class="seamTextUnorderedListItem">In addition, changes in stool microbiome with acupressure will be studied.</li> <li class="seamTextUnorderedListItem">The microbiome consists of the many bacteria, viruses, and fungi found on your body.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06228768' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05417308

Minoxidil for Hormone Therapy-Induced Hair Loss in People with Stage I-IV Breast Cancer

A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients Scientific Title

Purpose

To study the safety and ability of 2 methods of administering minoxidil to treat hair loss (alopecia) caused by hormone therapy.

Who is this for?

Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving treatment with tamoxifen (Nolvadex®) or an aromatase inhibitor and are experiencing hair loss. You must not have received chemotherapy within the last 2 years. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Topical Administration <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Minoxidil, by foam to scalp, daily for 1 year</li> </ul> Group 2: Oral Administration <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Minoxidil, by mouth, daily for 1 year</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">People receiving endocrine therapy, also called hormone therapy, commonly report hair loss or thinning. This side effect is called endocrine therapy-induced alopecia (EIA).</li> <li class="seamTextUnorderedListItem">Endocrine therapy-induced alopecia (EIA) is a distressing side effect that leads to reduced quality of life and early termination of hormone therapy in women with breast cancer.</li> <li class="seamTextUnorderedListItem">Minoxidil, sometimes called Rogaine®, is a drug that may promote hair growth and reduce hair loss.</li> <li class="seamTextUnorderedListItem">Oral minoxidil may work the same as topical minoxidil in treating EIA in people with breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05417308' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/hair-loss' target='_blank'>Breastcancer.org: Hair Loss (Alopecia)</a> </li></ul>

NEAREST SITE: 2108 miles
The Ohio State University
Columbus,OH

VISITS: 8 visits within 9 months

PHASE: NA

NCT ID: NCT05984888

MIND Diet and Nutrition Counseling to Improve Brain Function for People with Stage II-IV HR+ Breast Cancer

Protecting the Brain From Toxic Side Effects of Chemotherapy: a Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer Scientific Title

Purpose

To study the impact of the Neurodegenerative Delay (MIND) diet on your cognition (ability to think).

Who is this for?

Postmenopausal women 45 to 75 years old with stage II, stage III, or stage IV (metastatic) hormone receptor positive (ER+ and/or PR+) breast cancer who are planning to begin treatment within 1 month. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nutrition counseling about the MIND diet, 8 in-person sessions within 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General health (non-diet) counseling, 8 in-person sessions within 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cancer treatment can lead to cognition (ability to think) problems and low quality of life.</li> <li class="seamTextUnorderedListItem">The Neurodegenerative Delay (MIND) diet is high in anti-inflammatory nutrients (omega-3, carotenoids, B vitamins, etc.) and limits foods that are not healthy for the brain (butter, cheese, red meat, fried foods, sugar, etc.).</li> <li class="seamTextUnorderedListItem">The MIND diet may help improve brain function during cancer treatment.</li> <li class="seamTextUnorderedListItem">Cognition is your ability to think.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05984888' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://health.osu.edu/wellness/exercise-and-nutrition/the-mind-diet' target='_blank'>Ohio State University: The MIND Diet and Brain Health</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/21032-chemo-brain' target='_blank'>Cleveland Clinic: Chemotherapy and Brain Function Problems</a> </li></ul>

NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05503251

Improving Quality of Life and Cognitive Function After Radiation Therapy for People with Brain Metastases

Effect of Early Integrated Neuropsychological Care in Patients With Brain Metastases - A Phase 2 Randomized Controlled Trial Scientific Title

Purpose

To study if neuropsychological evaluations can improve quality of life or cognitive function after radiation.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive radiation. You must not have previously received whole brain radiation therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neuropsychological evaluations, 3 times within 6 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No neuropsychological evaluations</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Quality of life refers to the overall enjoyment of life. It holds varying meanings for different people and may evolve over time. For some individuals it implies autonomy, empowerment, capability, and choice; for others, security, social integration, or freedom from stress or illness.</li> <li class="seamTextUnorderedListItem">Neuropsychological evaluation is used to examine the cognitive consequences of brain damage, brain disease, and severe mental illness.</li> <li class="seamTextUnorderedListItem">Cognition is your ability to think.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05503251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: 1 visit every 1-2 weeks for 1-2 months

PHASE: II-III

NCT ID: NCT04862585

Safely Stopping Pre-Medications During Chemotherapy for Breast Cancer

Safely Stopping Pre-Medications in Patients Receiving Paclitaxel: A Randomized Trial Scientific Title

Purpose

To study the safety and side effects of stopping pre-medications during treatment with paclitaxel (Taxol®).

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive chemotherapy. You must not have received paclitaxel (Taxol®). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every 1-2 weeks, 4 sessions</li> <li class="seamTextUnorderedListItem">Dexamethasone, by mouth or IV</li> <li class="seamTextUnorderedListItem">Diphenhydramine, by mouth or IV</li> <li class="seamTextUnorderedListItem">Famotidine (Pepcid®), ranitidine, or cimetidine (Tagamet®), by mouth or IV</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every 1-2 weeks, 2 sessions</li> <li class="seamTextUnorderedListItem">Dexamethasone, by mouth or IV</li> <li class="seamTextUnorderedListItem">Diphenhydramine, by mouth or IV</li> <li class="seamTextUnorderedListItem">Famotidine (Pepcid®), ranitidine, or cimetidine (Tagamet®), by mouth or IV</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every 1-2 weeks, 2 sessions</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug that blocks cancer cell growth by stopping cell division which kills cancer cells.</li> <li class="seamTextUnorderedListItem">Pre-medications help prevent paclitaxel (Taxol®) side effects.</li> <li class="seamTextUnorderedListItem">Pre-medications include: dexamethasone, diphenhydramine, famotidine (Pepcid®), ranitidine, and cimetidine (Tagamet®).</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will stop taking pre-medications after your second paclitaxel (Taxol®) dose.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04862585' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncologynurseadvisor.com/home/departments/ask-a-pharmacist/importance-of-sequence-in-administering-premeds-with-paclitaxel/#:~:text=Premedications%20are%20administered%20prior%20to,severity%20of%20infusion%2Drelated%20reactions.' target='_blank'>Oncology Nurse Advisor: Paclitaxel (Taxol®) Pre-Medications</a> </li></ul>

NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: 1 visit every week for 3 months

PHASE: I

NCT ID: NCT04205903

Nilotinib to Prevent Nerve Pain During Chemotherapy for People with Stage I-III Breast Cancer

A Phase Ib/II Study of the Safety and Pharmacology of Nilotinib to Prevent Paclitaxel-Induced Peripheral Neuropathy in Patients With Breast Cancer Scientific Title

Purpose

To study the safety and ability of nilotinib (Tasigna®) to prevent nerve pain during chemotherapy.

Who is this for?

People with stage I, stage II, or stage III breast cancer who are planning to receive paclitaxel (Taxol®). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Nilotinib, by mouth, 1-2 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Placebo for nilotinib, by mouth, 1-2 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neuropathy is nerve pain in your hands and feet as a side effect of cancer treatment such as chemotherapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Nilotinib (Tasigna®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04205903' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/neuropathy' target='_blank'>Breastcancer.org: Neuropathy (Nerve Pain)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>

NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05946668

Studying Vaginal Microbiome and Vaginal Health in Women with HR+, HER2- Stage I-III Breast Cancer

The VAginal Microbiome as a BiomaRker of VagInal Health in Women With BreaSt CancEr (ARISE) Scientific Title

Purpose

To study how the vaginal microbiome affects vaginal and sexual health.

Who is this for?

Women with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are planning to receive or receiving hormone therapy. You must be receiving care at the Ohio State University Medical Center. Full eligibility criteria

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You will complete the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Collect vaginal swabs using a self-collection kit</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy may affect sexual health and may cause women to stop having sex.</li> <li class="seamTextUnorderedListItem">The vaginal microbiome is the collection of all microorganisms, such as bacteria, fungi, and viruses, that naturally live inside the vagina. The vaginal microbiome may play a role in menopausal-related sexual health symptoms.</li> <li class="seamTextUnorderedListItem">A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05946668' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://rightasrain.uwmedicine.org/well/health/vaginal-microbiome' target='_blank'>University of Washington: The Vaginal Microbiome</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/vaginal-dryness' target='_blank'>Breastcancer.org: Vaginal Changes with Hormone Therapy</a> </li></ul>

NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: 2 visits in 2.5 months

PHASE: NA

NCT ID: NCT05677802

Stress Management Therapy for Women with Stage I-III Triple Negative Breast Cancer

Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients Scientific Title

Purpose

To study if stress management therapy reduces stress and addresses health-related social needs.

Who is this for?

Women with newly diagnosed stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stress management therapy, 10 sessions in 2.5 months</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times in 2.5 months</li> <li class="seamTextUnorderedListItem">Surveys</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The stress management therapy includes progressive muscle relaxation, coping, problem solving, communication, and social support.</li> <li class="seamTextUnorderedListItem">Health related social needs (such as utilities and transportation) will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05677802' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/living-beyond-breast-cancer/life-after-breast-cancer-treatment/coping-emotionally/managing-stress-anxiety#:~:text=After%20a%20diagnosis%20of%20breast,and%20cope%20better%20with%20anxiety' target='_blank'>Breast Cancer Now: Coping with Stress Following a Breast Cancer Diagnosis</a> </li></ul>

NEAREST SITE: 2113 miles
Thompson Proton Center
Knoxville,TN

VISITS: 1 visit every week for 2.5 months

PHASE: NA

NCT ID: NCT06006806

Reducing Skin Reactions From Proton Radiation Therapy for People with Stage 0-III Breast Cancer

Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy Scientific Title

Purpose

To study the ability of the "Spot Delete" method to reduce skin reactions during pencil beam scanning (PBS) proton radiation therapy.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or stage III breast cancer who have received surgery. You must not have received radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT scan, 1 time</li> <li class="seamTextUnorderedListItem">Pencil beam scanning (PBC) proton radiation therapy with <q>Spot Delete</q> method</li> <li class="seamTextUnorderedListItem">Digital photographs, weekly for 2.5 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Pencil beam scanning (PBS) proton therapy may safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor.</li> <li class="seamTextUnorderedListItem">Radiation therapy, including pencil beam scanning proton therapy, can cause skin reactions.</li> <li class="seamTextUnorderedListItem">The <q>Spot Delete</q> method may prevent protons from stopping in the skin, which is thought to cause skin redness.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06006806' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/21995-radiation-burns' target='_blank'>Cleveland Clinic: Skin Reactions from Radiation Therapy</a> </li></ul>

NEAREST SITE: 2137 miles
Emory University Hospital Midtown
Atlanta,GA

VISITS: 1 visit every day for 2 weeks

PHASE: NA

NCT ID: NCT05368428

Transcutaneous Electrical Nerve Stimulation for Chemotherapy Induced Peripheral Neuropathy in People with Stage I-III Breast Cancer

Single-Institution Trial Investigating the Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) in Taxane Induced Peripheral Neuropathy (CIPN) in Patients With Early Stage Breast Cancer Scientific Title

Purpose

To determine if transcutaneous electrical nerve stimulation (TENS) reduces chemotherapy induced peripheral neuropathy (CIPN).

Who is this for?

People with stage I, stage II, or stage III breast cancer who are receiving chemotherapy and have chemotherapy induced peripheral neuropathy (CIPN). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Transcutaneous electrical nerve stimulation (TENS), daily for 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy induced peripheral neuropathy (CIPN) is nerve pain in your hands and feet as a side effect of chemotherapy.</li> <li class="seamTextUnorderedListItem">Neuropathy is pain from nerve damage.</li> <li class="seamTextUnorderedListItem">Transcutaneous electrical nerve stimulation (TENS) involves mild electric currents applied to some areas of your skin to potentially improve neuropathy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05368428' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/treatments/15840-transcutaneous-electrical-nerve-stimulation-tens' target='_blank'>Cleveland Clinic: Transcutaneous Electrical Nerve Stimulation (TENS)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/neuropathy' target='_blank'>Breastcancer.org: Neuropathy</a> </li></ul>

NEAREST SITE: 2257 miles
AHN CI Exercise Oncology and Resiliency
Pittsburgh,PA

VISITS: 2-3 visits per week for 3 months

PHASE: NA

NCT ID: NCT05978960

Exercise and Nutrition for Women with DCIS or Stage I-IV Breast Cancer

An EXErcise Regimen Designed to Improve Body Composition, Functional Capacity, and Strength After Treatment for Breast Cancer With Nutrition Optimization Scientific Title

Purpose

To study whether exercise and diet changes can lead to lower body fat and higher body muscle.

Who is this for?

Women 20-89 years old with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving treatment (except for chemotherapy) or completed treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Resistance training classes, 2-3 times per week for 3 months</li> <li class="seamTextUnorderedListItem">Nutrition program</li> <li class="seamTextUnorderedListItem">Nutrition meetings, 6 times within 3 months</li> <li class="seamTextUnorderedListItem">Body composition measurements</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Excess body fat is a risk factor for breast cancer and is associated with an increased risk of cancer coming back (recurrence).</li> <li class="seamTextUnorderedListItem">The resistance training class goals are to increase strength, mobility, and muscle. The classes will be supervised by fitness professionals.</li> <li class="seamTextUnorderedListItem">The nutrition program goal is to avoid calorie counting and instead focus on food quality, maximizing protein, and limiting carbohydrates.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05978960' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/exercise' target='_blank'>Breastcancer.org: Exercise</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/coping-with-cancer/physical-emotional-and-social-effects-cancer/managing-physical-side-effects/weight-gain' target='_blank'>ASCO: Weight Gain During Breast Cancer Treatment</a> </li></ul>

NEAREST SITE: 2260 miles
Allegheny General Hospital
Pittsburgh,PA

VISITS: 3 times per week for 3 months

PHASE: NA

NCT ID: NCT06115486

Exercise to Improve Muscle Mass After Treatment for Stage 0-III Breast Cancer

EXERT-BCH: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer to Improve Hypertrophy Scientific Title

Purpose

To compare the ability of 2 group exercise programs to increase muscle mass for women after breast cancer treatment.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or stage III breast cancer who have completed treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Resistance training in a small group, 3 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Strength measurements</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Strength and conditioning training in a small group, 3 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Strength measurements</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exercise to build muscle mass in people who have been treated for breast cancer may reduce toxicity from treatment, increase time to tumor progression, and prolong survival.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06115486' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2299 miles
Roswell Park Cancer Institute
Buffalo,NY

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05787834

Home-Based Respiratory Muscle Training to Reduce Chemotherapy Side Effects for People with Stage I-IV Breast Cancer

Respiratory Muscle Training During Breast Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity Scientific Title

Purpose

To study how home-based respiratory muscle training is useful for minimizing side effects during chemotherapy treatment.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive chemotherapy. You must not have received radiation to the left chest wall. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Usual care, 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Respiratory muscle training using a respiratory muscle training device, 1.5 months (optional)</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Respiratory muscle training using a respiratory muscle training device, 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Respiratory muscle training is a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training.</li> <li class="seamTextUnorderedListItem">Respiratory muscle training may decrease heart and lung side effects of chemotherapy and improve your quality of life.</li> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05787834' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://umiamihealth.org/en/treatments-and-services/ear,-nose,-and-throat-(ent)/speech-therapy/respiratory-muscle-training#:~:text=Respiratory%20muscle%20training%20(RMT)%20is,%2C%20improve%20respiration%20(breathing).' target='_blank'>University of Miami: Respiratory Muscle Training</a> </li></ul>

NEAREST SITE: 2314 miles
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem,NC

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03987555

Studying the Amount of Chemotherapy in the Blood in People with Breast Cancer

Pilot Feasibility Study of Paclitaxel Therapeutic Drug Monitoring in Cancer Patients Scientific Title

Purpose

To study the ability of researchers to measure the amount of paclitaxel (Taxol®) in blood and study the effect of paclitaxel (Taxol®) on neuropathy.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive treatment with paclitaxel (Taxol®) at Wake Forest Comprehensive Cancer Center. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws</li> <li class="seamTextUnorderedListItem">Surveys about neuropathy</li> </ul> Please contact research site for trial schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Neuropathy is pain from nerve damage.</li> <li class="seamTextUnorderedListItem">Nerve damage is one of the most common and severe side effects of paclitaxel (Taxol®).</li> <li class="seamTextUnorderedListItem">The ability to consistently measure paclitaxel (Taxol®) in the blood may allow doctors to control the dose of paclitaxel, so that enough chemotherapy is given to kill the cancer, but the side effect of nerve damage is reduced.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03987555' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/paclitaxel-taxol' target='_blank'>Breast Cancer Now: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/side_effects/neuropathy' target='_blank'>Breastcancer.org: Neuropathy</a> </li></ul>

NEAREST SITE: 2314 miles
Wake Forest University Health Sciences
Winston-Salem,NC

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03955627

Exercise and Education Program to Reduce Joint Pain During Hormone Therapy for Older Women with Stage I-III Breast Cancer

Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study Scientific Title

Purpose

To study the ability of an exercise and education program to reduce joint pain during treatment with aromatase inhibitors.

Who is this for?

Women at least 60 years old with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who have completed surgery, radiation, and/or chemotherapy and complete less than 2.5 hours of exercise each week. You must have begun treatment with an aromatase inhibitor within the last 6 months or be planning to receive treatment with an aromatase inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Virtual group exercise and education sessions, 2 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Home-based group exercise and education sessions, 2 months</li> <li class="seamTextUnorderedListItem">Calls with coaches, every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Brochure about hormonal therapy</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Enhanced Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brochure about hormonal therapy use</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Joint pain is a common side effect of aromatase inhibitors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03955627' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rogelcancercenter.org/living-with-cancer/mind-body-and-side-effects/aromatase-inhibitors-treatment-related-pain-and-what' target='_blank'>University of Michigan: Aromatase Inhibitors and Joint Pain</a> </li></ul>

NEAREST SITE: 2314 miles
Wake Forest Baptist Health Sciences
Winston-Salem,NC

VISITS: 3 visits in 3 months

PHASE: NA

NCT ID: NCT05030038

Impact of Aromatase Inhibitors on Gut Bacteria in People with Stage 0-IV Breast Cancer

Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability Scientific Title

Purpose

To study the bacteria in your gut before and during treatment with an aromatase inhibitor.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) hormone receptor positive (ER+ and/or PR+) breast cancer who are receiving an aromatase inhibitor, or women without breast cancer who are receiving an aromatase inhibitor to reduce their risk of breast cancer. You must not have received antibiotics within the last month. If you have HER2 positive (HER2+) breast cancer, you must not have received an antibody drug conjugate (ADC). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests, 3 times within 3 months</li> <li class="seamTextUnorderedListItem">Stool samples, 3 times within 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The microbiome consists of the many bacteria, viruses, and fungi found in your digestive tract. Most of the microbiome consists of bacteria in your digestive system.</li> <li class="seamTextUnorderedListItem">These bacteria can be beneficial or harmful. The harmful bacteria cause disease, and the beneficial bacteria help keep you healthy.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor-positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">You will collect fecal samples at home and either mail in the sample or drop it off at the lab.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05030038' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hsph.harvard.edu/nutritionsource/microbiome/' target='_blank'>Harvard University: What is the Microbiome?</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/about-us/news-personal-stories/can-gut-bacteria-help-treat-breast-cancer' target='_blank'>Breast Cancer Now: Gut Bacteria and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li></ul>

NEAREST SITE: 2352 miles
University of Rochester
Rochester,NY

VISITS: 6 visits over 3-5 months

PHASE: NA

NCT ID: NCT03137095

Memory Problems During Chemotherapy in People with Stage I-III Breast Cancer

Longitudinal Pilot Mechanistic Study of the Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants Scientific Title

Purpose

To study if and how your cognitive functioning skills, like memory and concentration, change as you receive chemotherapy.

Who is this for?

Women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning to receive chemotherapy, and women who do not have breast cancer. Full eligibility criteria

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You will undergo the following over 3-5 months: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">6 cognitive tests, during chemotherapy and 1 month after chemotherapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive tests study your cognition, which is your ability to think.</li> <li class="seamTextUnorderedListItem">Women without breast cancer will also be enrolled for comparison.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03137095' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/managing-cancer/side-effects/changes-in-mood-or-thinking/chemo-brain.html' target='_blank'>American Cancer Society: What is Chemo Brain?</a> </li></ul>

NEAREST SITE: 2371 miles
University of Virginia University Hospital
Charlottesville,VA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05786014

Exercise to Reduce Heart Problems During Chemotherapy for Women with Stage I-IV Breast Cancer

A Feasibility Study to Examine Two Remotely-monitored Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies Scientific Title

Purpose

To study if exercise training can reduce side effects and improve quality of life during chemotherapy treatment.

Who is this for?

Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Moderate Intensity Walking <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Moderate intensity walking, 2.5 hours every week</li> <li class="seamTextUnorderedListItem">Text messages, phone calls, and emails from study staff</li> <li class="seamTextUnorderedListItem">Blood tests, 4 times</li> <li class="seamTextUnorderedListItem">Heart tests, 2 times</li> </ul> Group 2: High Intensity Biking <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">High intensity exercise on stationary bike, 3 days every week, 2 times in person, then at home</li> <li class="seamTextUnorderedListItem">Text messages, phone calls, and emails from study staff</li> <li class="seamTextUnorderedListItem">Blood tests, 4 times</li> <li class="seamTextUnorderedListItem">Heart tests, 2 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exercise may help prevent heart problems caused by breast cancer chemotherapy.</li> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">Moderate intensity walking involves breaking a sweat and increased breathing while still being able to talk.</li> <li class="seamTextUnorderedListItem">The exercise programs will be remotely monitored.</li> <li class="seamTextUnorderedListItem">If you are in group 1, you will receive walking shoes.</li> <li class="seamTextUnorderedListItem">If you are in group 2, you will receive a stationary bike to exercise at home.</li> <li class="seamTextUnorderedListItem">The text messages, phone calls, and emails from study staff will encourage participation and physical activity.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05786014' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/16858-chemotherapy--the-heart-cardiotoxicity#:~:text=Certain%20cancer%20treatments%20may%20cause,cancer%2C%20sarcoma%20or%20multiple%20myeloma.' target='_blank'>Cleveland Clinic: Heart Problems Caused by Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.myfitnesspal.com/what-counts-as-moderate-intensity-walking/' target='_blank'>My Fitness Pal: What is Moderate Intensity Walking?</a> </li></ul>

NEAREST SITE: 2383 miles
Mayo Clinic in Florida
Jacksonville,FL

VISITS: Coincides with surgery

PHASE: II

NCT ID: NCT06153836

Nerve Reconstruction to Maintain Feeling in the Nipple After Mastectomy for Women with Stage 0-II Breast Cancer

Randomized Feasibility Study to Determine the Feasibility of Neurotization of the Nipple Areolar Complex at the Time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction Scientific Title

Purpose

To study if a surgical technique using a nerve graft, also called nerve reconstruction, will maintain feeling in the nipple after a nipple-sparing mastectomy.

Who is this for?

Women with stage 0 (DCIS), stage I, or stage II node negative breast cancer who are planning to receive a nipple-sparing mastectomy and have not had previous breast radiation, breast reduction, or breast augmentation. You must have a bra cup size of A to C. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care nipple-sparing mastectomy</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care nipple-sparing mastectomy with nerve graft</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A mastectomy is surgery to remove the breast.</li> <li class="seamTextUnorderedListItem">Nerve damage can occur during a mastectomy. When nerves are damaged, you may feel numbness, also known as loss of sensation.</li> <li class="seamTextUnorderedListItem">A nerve graft, also called nerve reconstruction, replaces nerves damaged during the mastectomy.</li> <li class="seamTextUnorderedListItem">This nerve graft surgery can be performed during nipple-sparing mastectomy and reconstruction and may maintain feeling in the nipple and improve quality of life.</li> <li class="seamTextUnorderedListItem">Node negative means cancer has not spread to your lymph nodes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06153836' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nebraskamed.com/cancer/breast-cancer/breast-reconstruction/mastectomies-and-nipples-what-are-the-options-for-breast-reconstruction' target='_blank'>University of Nebraska: Restoring Nipple Sensation After Mastectomy</a> </li></ul>

NEAREST SITE: 2383 miles
Mayo Clinic
Jacksonville,FL

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT04742231

Measuring Hand Strength During Brain Surgery to Predict How the Craniotomy Will Affect Motor Skills

Use of Handheld Dynamometer as a Novel Tool to Assess Motor Function During Awake Craniotomy for Brain Lesions Located Within or Adjacent to the Motor Cortex: A Single-Center Pilot Study Scientific Title

Purpose

To study the safety and reliability of measuring hand strength during an awake craniotomy to monitor how the surgery will affect your motor skills.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and who will have an awake craniotomy at the Mayo Clinic in Jacksonville, Florida. Full eligibility criteria

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Your hand strength will be measured during surgery with a handheld device called a K-FORCE Grip dynamometer®.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A craniotomy is a type of brain surgery. The surgeon will remove part of your skull (cranium) to access your brain to remove the tumors. </li> <li class="seamTextUnorderedListItem">You will be awake during the craniotomy so that you can use a handheld device to monitor how the surgery is affecting your motor skills. </li> <li class="seamTextUnorderedListItem">Motor skills are body movements and include walking, hand movements (like writing), and other types of movement. </li> <li class="seamTextUnorderedListItem">K-FORCE Grip® is a handheld dynamometer. A dynamometer is a machine that is held in the hand and can measure the strength of your grip. </li> <li class="seamTextUnorderedListItem">Researchers believe measuring grip strength may predict how removing tumors will affect motor skills.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04742231' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/craniotomy' target='_blank'>Johns Hopkins Medicine: Craniotomy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/awake-brain-surgery/about/pac-20384913' target='_blank'>Mayo Clinic: Awake Brain Surgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://k-invent.com/produit/k-force-grip/' target='_blank'>Kinvent Device Information Page: KForce Grip</a> </li></ul>

NEAREST SITE: 2383 miles
Mayo Clinic in Florida
Jacksonville,FL

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT05507879

Registry to Study Heart Problems from Chemotherapy in People with Stage I-III Breast Cancer

Characterization of TRPC6 to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure (Prospective Study) Scientific Title

Purpose

To study the TRPC6 biomarker to predict and prevent chemotherapy-related cardiac toxicity.

Who is this for?

People with stage I, stage II, or stage III breast cancer who are receiving or are planning to receive chemotherapy or trastuzumab (Herceptin®). Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">Understanding how the TRPC6 biomarker is involved in these changes may allow early intervention against cardiac toxicity and also identify new biomarkers to protect long-term cardiac health.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05507879' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/16858-chemotherapy--the-heart-cardiotoxicity#:~:text=Cardiotoxicity%20is%20a%20term%20for,radiation%20therapy%20to%20the%20chest.' target='_blank'>Cleveland Clinic: Cardiotoxicity and Cancer Treatment</a> </li></ul>

NEAREST SITE: 2406 miles
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill,NC

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04073966

MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets

Magnetic Resonance Imaging Biomarkers for Radiation-Induced Neurocognitive Decline Following Stereotactic Radiosurgery of Newly Diagnosed Brain Metastases: An Observational Pilot Study Scientific Title

Purpose

To study why radiation causes brain function changes to help doctors predict and prevent brain function changes.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are receiving stereotactic radiosurgery (SRS). You must not have received surgery to the lesion receiving SRS or any radiation to the brain or head. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Neurocognitive function tests</li> </ul> Please contact research site for trial schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS) is a type of radiation therapy that delivers a high dose of radiation only to the areas of cancer in the brain and avoids the surrounding normal brain tissue.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04073966' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: 2-4 visits

PHASE: NA

NCT ID: NCT01231932

Studying Fatigue in People with Stage I-IV Breast Cancer and Breast Cancer Survivors

Characterizing Fatigue Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors Scientific Title

Purpose

To understand how the immune system and body change during cancer treatment, how these changes cause fatigue, and how quality of life is affected by fatigue.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving treatment, or have recently completed standard treatment for primary breast cancer. Full eligibility criteria

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You will complete the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physical exam</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Physical activity tracking with wearable device</li> <li class="seamTextUnorderedListItem">Journaling</li> <li class="seamTextUnorderedListItem">Cognitive games (optional)</li> <li class="seamTextUnorderedListItem">Strength test (optional)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fatigue is a common side effect of cancer and treatment. Previous research has shown that fatigue may be caused by a number of factors, including problems with the immune system response of the body while undergoing cancer treatment.</li> <li class="seamTextUnorderedListItem">A wearable device, such as a Fitbit, is device you wear that tracks your physical activity.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01231932' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/fatigue' target='_blank'>Breastcancer.org: Fatigue</a> </li></ul>

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Requires hospitalization

PHASE: NA

NCT ID: NCT02639325

Brain Surgery for Brain Metastasis and Tumor Related Epilepsy

Tumor Related Epilepsy Scientific Title

Purpose

To study if brain surgery reduces the number of seizures and to see how surgery affects seizures.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have no more than one brain tumor and have experienced at least one seizure associated with the tumor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires hospitalization for at least one week</li> <li class="seamTextUnorderedListItem">Questionnaires, cognitive assessments, and seizure diary</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some people with brain tumors have seizures related to the tumor. This is called tumor-related epilepsy. </li> <li class="seamTextUnorderedListItem">Researchers think surgery may improve outcomes for people with tumor-related epilepsy by stopping seizures or reducing the number of seizures.</li> <li class="seamTextUnorderedListItem">Cognitive assessments study your cognition, which is your ability to think.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02639325' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/brain-metastasis/' target='_blank'>MBCBrainMets.org: About Brain Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/treatments-brain-metastasis/#toggle-id-7' target='_blank'>MBCBrainMets.org: Brain Metastasis Treatments</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/brain-mets/' target='_blank'>Metastastic Trial Talk: Treating Breast Cancer Brain Mets</a> </li></ul>

NEAREST SITE: 2433 miles
Sibley Memorial Hospital
Washington,DC

VISITS: Please contact the research site

PHASE: NA

NCT ID: NCT03223922

Preserving Cognitive Function With Whole Brain Radiation Therapy for Brain Metastases

Preservation of Cognition and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study Scientific Title

Purpose

To evaluate how well genu-sparing whole brain radiation preserves cognitive function in patients with brain metastases.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) that has not been treated with whole brain radiation therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genu-sparing whole brain radiation therapy, once a day, 5 days a week</li> <li class="seamTextUnorderedListItem">Cognitive testing at baseline and at 4 , 6 and 12 months following completion of brain radiation</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genu-sparing whole brain radiation limits the radiation dose to a specific area in the brain (the genu of the corpus callosum).</li> <li class="seamTextUnorderedListItem">The genu (front part) of the corpus callosum is associated with cognitive and neuropsychiatric functioning.</li> <li class="seamTextUnorderedListItem">Researchers believe that reducing damage to this area may prevent the decline of cognitive and neuropsychiatric functioning.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03223922' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>

NEAREST SITE: 2434 miles
Georgetown Lombardi Comprehensive Cancer Center
Washington,DC

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05256745

Azeliragon to Decrease Cardiotoxicity and Cognitive Decline During Chemotherapy in Women with Stage I-III Breast Cancer

RAGE Inhibition to Decrease Cancer Therapy Related Cardio Toxicity in Women With Early Breast Cancer Scientific Title

Purpose

To study the ability of azeliragon to decrease cardiotoxicity (heart damage caused by cancer treatment) and cognitive decline side effects of chemotherapy.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who have not yet received treatment and are planning to receive chemotherapy. Full eligibility criteria

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You will be assigned to 1 of 4 groups: Group 1: Azeliragon with AC/T Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), 5.5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 5.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 5.5 months</li> </ul> Group 2: Azeliragon with CT Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 3-4 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 3-4 months</li> </ul> Group 3: Azeliragon with TCHP Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 4 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), 4 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), 4 months</li> </ul> Group 4: Azeliragon with Combination of Chemotherapy and Targeted Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 4 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 3-4 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 5.5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), depending on type of cancer</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 months, depending on type of cancer</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon is an experimental drug that may reduce cardiotoxicity and cognitive decline side effects of chemotherapy. It is also being studied for treating Alzheimer's and glioblastoma, a type of brain cancer.</li> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity. </li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), paclitaxel (Taxol®), docetaxel (Taxotere®), and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and Pertuzumab (Perjeta®) are anti-HER2 targeted therapies routinely used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05256745' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/16858-chemotherapy--the-heart-cardiotoxicity#:~:text=Cardiotoxicity%20refers%20to%20any%20heart,radiation%20therapy%20to%20the%20chest.' target='_blank'>Cleveland Clinic: Cardiotoxicity Cancer Treatment and the Heart</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/fda-grants-orphan-drug-designation-to-azeliragon-for-gbm' target='_blank'>OncLive: Azeliragon for Brain Cancer and Cancer Treatment-Related Complications</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 2436 miles
MedStar Washington Hospital Center
Washington,DC

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05233800

Faster Asleep Smart Speaker for Sleep Problems in Women with Breast Cancer

Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors Scientific Title

Purpose

To study if the Faster Asleep Smart Speaker Program can reduce insomnia and help you sleep better.

Who is this for?

Women with stage I, stage II, stage III, or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Faster Asleep Smart Speaker Program, daily for 6 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Faster Asleep Website</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Faster Asleep Smart Speaker Program includes a speaker that can be activated by your voice or smartphone app. It automatically delivers components of cognitive behavioral therapy for insomnia (sleep problems).</li> <li class="seamTextUnorderedListItem">The Faster Asleep Website has information about cognitive behavioral therapy for insomnia (sleep problems) in people with breast cancer, including information from the Faster Asleep Smart Speaker Program script.</li> <li class="seamTextUnorderedListItem">Cognitive behavioral therapy helps connect the way we think (cognition), the things we do, and how we sleep.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05233800' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sleepfoundation.org/insomnia/treatment/cognitive-behavioral-therapy-insomnia' target='_blank'>Sleep Foundation: Cognitive Behavioral Therapy for Insomnia</a> </li></ul>

NEAREST SITE: 2454 miles
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,MD

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05386719

Screening for Diabetes, High Cholesterol, and Heart Disease in People with Breast Cancer After Treatment

A Cardiometabolic Screening Program for Breast Cancer Survivors Scientific Title

Purpose

To study a screening program for prediabetes, diabetes, high cholesterol, and heart disease in breast cancer survivors, as well as a program to direct people to resources for management.

Who is this for?

People with stage I, stage II, or stage III breast cancer who completed treatment at least 3 months ago. You must be receiving care at Johns Hopkins Medical Institute; Sidney Kimmel Comprehensive Cancer Center in Baltimore, MD; Green Spring Station in Lutherville-Timonium, MD; or Sibley Memorial Hospital in Washington, DC. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests, 1-2 times in 1 year</li> <li class="seamTextUnorderedListItem">Referral to primary care, nutrition, exercise, hormone health, and/or heart health provider(s) based on risk factors</li> <li class="seamTextUnorderedListItem">Educational handouts based on risk factors</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Prediabetes, diabetes, high cholesterol, and being overweight/obese are common in people with early stage breast cancer.</li> <li class="seamTextUnorderedListItem">The Healthful Eating, Activity and Weight Program (HEAWP) and Cardiovascular Disease Prevention Program are designed to help people manage these conditions.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05386719' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/gim/clinical/lifestyle-weight/' target='_blank'>Johns Hopkins: Healthful Eating, Activity and Weight Program</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/wellness-and-prevention/preventing-cardiovascular-diseases' target='_blank'>Johns Hopkins: Preventing Cardiovascular Diseases</a> </li></ul>

NEAREST SITE: 2517 miles
University of Pennsylvania
Philadelphia,PA

VISITS: 4 visits in 1 year, then 1 visit every 1-2 years

PHASE: NA

NCT ID: NCT05078190

Studying Cardiotoxicity in People with Stage I-IV Breast Cancer

Cardiotoxicity of Cancer Therapy 2: Mechanisms, Predictors, and Social Determinants of Health in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab Scientific Title

Purpose

To study how doxorubicin (Adriamycin®) chemotherapy and/or trastuzumab (Herceptin®) anti-HER2 targeted therapy affect your heart and how these effects relate to your medical history and social determinants of health (SDOH).

Who is this for?

Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer receiving or planning to receive treatment with doxorubicin (Adriamycin®) and/or trastuzumab (Herceptin®). You must be receiving care at Abramson Cancer Center. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Echocardiograms</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">Social determinants of health (SDOH) describe non-medical factors that influence your health, such as race, gender identity, education, occupation, access to health services and economic resources.</li> <li class="seamTextUnorderedListItem">An electrocardiogram (ECG) test records electrical signals in your heart.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05078190' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/about/sdoh/index.html' target='_blank'>Centers for Disease Control and Prevention: Social Determinants of Health (SDOH)</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/16858-chemotherapy--the-heart-cardiotoxicity#:~:text=Cardiotoxicity%20is%20a%20term%20for,radiation%20therapy%20to%20the%20chest.' target='_blank'>Cleveland Clinic: Cardiotoxicity and Cancer Treatment</a> </li></ul>

NEAREST SITE: 2519 miles
Thomas Jefferson University Hopsital
Philadelphia,PA

VISITS: Number of visits unavailable, over 2 months

PHASE: NA

NCT ID: NCT06219434

Mindfulness to Prevent Chemo Brain for Women with Stage I-IV Breast Cancer

Pilot Feasibility Evaluation of a Mindfulness (Mindfulness) Intervention in Women Preparing for Chemotherapy for Breast Cancer Scientific Title

Purpose

To study how well a mindfulness program helps prevent "chemo brain".

Who is this for?

Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mindfulness program: practice mindfulness for 2.5 hours/week for 2 months </li> <li class="seamTextUnorderedListItem">MRI scan, 1 time</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Difficulty thinking, known as cognitive dysfunction or <q>chemo brain</q>, is common after chemotherapy. </li> <li class="seamTextUnorderedListItem">Mindfulness is a type of meditation that can support well-being, decrease stress, and increase awareness of the present moment without judgment. </li> <li class="seamTextUnorderedListItem">In this trial, the mindfulness program includes mindfulness of breathing and body scans, mindful eating, mindful activity, mindfulness in daily life, expanding the field of awareness, and maintaining a flexible mindfulness practice.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06219434' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2521 miles
Fox Chase Cancer Center
Philadelphia,PA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05636943

Improving Sexual and Emotional Intimacy for Women with Metastatic Breast Cancer

Quality of Life for Couples Facing Metastatic Breast Cancer Scientific Title

Purpose

To study whether intimacy enhancement sessions improve sexual and emotional intimacy for women with metastatic breast cancer and their romantic partners.

Who is this for?

Women with stage IV (metastatic) breast cancer who live with a romantic partner (same or opposite sex) for at least 6 months and have sexual intimacy concerns. Full eligibility criteria

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You and your romantic partner will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive intimacy enhancement sessions with partner, 4 virtual sessions</li> <li class="seamTextUnorderedListItem">Read a booklet with partner about intimacy and metastatic breast cancer</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Read a booklet with partner about intimacy and metastatic breast cancer</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">3 surveys over 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Intimacy enhancement sessions are virtual 60-75 minute sessions with a couples coach consisting of education and skills to enhance physical and emotional intimacy.</li> <li class="seamTextUnorderedListItem">The booklet contains self-guided readings and resources about intimacy and metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">This trial requires participation from you and your partner.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05636943' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/metastatic/sexuality' target='_blank'>Breastcancer.org: Sexuality and Metastatic Breast Cancer</a> </li></ul>

NEAREST SITE: 2531 miles
Virtua Health
Voorhees,NJ

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05704842

Exercise to Reduce Fatigue During Chemotherapy for Women with Stage I-III Breast Cancer

Pilot Study to Evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy Scientific Title

Purpose

To study if exercise reduces fatigue during treatment with chemotherapy.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who plan to receive chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Visit with physical therapist</li> <li class="seamTextUnorderedListItem">Complete home-based exercise program</li> <li class="seamTextUnorderedListItem">Complete online surveys, weekly</li> </ul> Group 2: Standard Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Complete online surveys, weekly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The home-based exercise program includes exercises such as: core stabilization, core extension, leg extensions, squats with and without weights, shoulder exercises, and arm exercises.</li> <li class="seamTextUnorderedListItem">The online surveys will assess your symptoms and fatigue.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05704842' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/fatigue' target='_blank'>Breastcancer.org: Cancer Fatigue</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 1 visit every month

PHASE: I-II

NCT ID: NCT06110793

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER Low, HER2- Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor, pembrolizumab (Keytruda®) PD-1 inhibitor, and fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) breast cancer who have received hormone therapy with a CDK4/6 inhibitor for advanced disease. You must not have received more than 2 lines of chemotherapy for advanced disease or a PD-1/PD-L1 inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by IV, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06110793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge,NJ

VISITS: Coincides with surgery

PHASE: III

NCT ID: NCT03351348

Bupivacaine to Reduce Pain After Mastectomy for DCIS and Stage I-III Breast Cancer

Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction Scientific Title

Purpose

To study the ability of bupivacaine with standard of care pain medications to reduce pain after a mastectomy.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or some stage III breast cancer planning to receive a unilateral mastectomy without immediate reconstruction at Memorial Sloan Kettering Cancer Center. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for bupivacaine, by surgical drain</li> <li class="seamTextUnorderedListItem">Standard of care pain medications</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bupivacaine, by surgical drain</li> <li class="seamTextUnorderedListItem">Standard of care pain medications</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires, 2 times within 1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bupivacaine is a FDA-approved numbing medicine used for some surgical and dental procedures.</li> <li class="seamTextUnorderedListItem">The addition of bupivacaine to the surgical wound site with standard of care pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03351348' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/bupivacaine-injection-route/description/drg-20406723#:~:text=Bupivacaine%20injection%20is%20used%20to,It%20is%20a%20local%20anesthetic.' target='_blank'>Mayo Clinic: Bupivacaine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/mastectomy/expert-answers/pain-after-breast-surgery/faq-20058049' target='_blank'>Mayo Clinic: Pain After Breast Surgery</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge
Basking Ridge,NJ

VISITS: 1 visit per week for 1-3 months

PHASE: II

NCT ID: NCT05458284

Acupuncture for Nerve Pain During Chemotherapy for People with Breast Cancer

Acupuncture for Taxane-Induced Peripheral Neuropathy Prevention (ATP): A Phase II Randomized, Placebo Controlled Trial Scientific Title

Purpose

To study if acupuncture can prevent nerve pain from getting worse while receiving chemotherapy.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive treatment with paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®) chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Acupuncture, weekly for 1-3 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for acupuncture, weekly for 1-3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some people experience a side effect while they are receiving taxane chemotherapy called taxane-induced peripheral neuropathy (TIPN).</li> <li class="seamTextUnorderedListItem">TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life.</li> <li class="seamTextUnorderedListItem">Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body.</li> <li class="seamTextUnorderedListItem">We will compare real acupuncture (RA) to placebo (sham) acupuncture (SA). SA is done like RA, but will use different needles and target different sites or places on the body than RA.</li> <li class="seamTextUnorderedListItem">This trial is available in English or Spanish.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05458284' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/complementary-therapy/types/acupuncture' target='_blank'>Breastcancer.org: Acupuncture</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge,NJ

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05190770

Oleogel-S10 Gel for Radiation Dermatitis in People with Breast Cancer

A Randomized Phase II Study of the Efficacy of Oleogel-S10 (AP101) Gel for the Treatment of Grade 2/3 Radiation Dermatitis in Breast Cancer Patients Scientific Title

Purpose

To study whether oleogel-S10 is an effective treatment for radiation dermatitis in combination with triamcinolone, a standard of care wound treatment cream.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving radiation therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Triamcinolone, by cream, daily, 3 weeks</li> <li class="seamTextUnorderedListItem">Oleogel-S10, by gel, daily, 3 weeks</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Triamcinolone, by cream, daily, 3 weeks</li> <li class="seamTextUnorderedListItem">Placebo for oleogel-S10, by gel, daily, 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oleogel-S10 is an experimental gel consisting of birch bark extract and sunflower oil. It has shortened the healing time for other types of skin wounds such as burns and may also help treat radiation dermatitis.</li> <li class="seamTextUnorderedListItem">Triamcinolone is a cream that is frequently used to treat moderate to severe skin conditions such as skin irritation caused by poison ivy, eczema, sunburn, and rashes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05190770' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a601124.html' target='_blank'>Medline Plus: Triamcinolone</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/oleogel-s10' target='_blank'>National Cancer Institute: Oleogel-S10</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/21995-radiation-burns#:~:text=Radiation%20burn%20or%20radiation%20dermatitis,peel%2C%20itch%20or%20turn%20red.' target='_blank'>Cleveland Clinic: Radiation Dermatitis</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05910294

Preventing and Improving Sexual Health Concerns for People with DCIS and Stage I-III Breast Cancer

Randomized Pilot Prevention Trial to Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression Scientific Title

Purpose

To study whether sexual health counseling and using a non-hormonal vaginal moisturizer at the start of hormone therapy may prevent or reduce sexual side effects.

Who is this for?

Premenopausal or perimenopausal women with stage 0 (DCIS), stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who are receiving or planning to receive hormone therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive recommendations for vaginal moisturizers</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sexual health counseling</li> <li class="seamTextUnorderedListItem">Receive non-hormonal moisturizers, 3-5 times per week</li> <li class="seamTextUnorderedListItem">Consultation with pelvic floor physical therapist</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">If you are in group 1, you will receive recommendations for vaginal moisturizers but will purchase the moisturizers at your local pharmacy.</li> <li class="seamTextUnorderedListItem">If you are in group 2, you will receive non-hormonal vaginal moisturizers, such as: Hyalogyn, Replens, Liquibeads, or Vitamin E capsules.</li> <li class="seamTextUnorderedListItem">Sexual side effects include vaginal dryness and sexual dysfunction.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05910294' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/sex-intimacy' target='_blank'>Breastcancer.org: Sexual Health During and After Breast Cancer</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge,NJ

VISITS: 1-4 visits within 1 month

PHASE: II

NCT ID: NCT05966584

Benralizumab to Prevent Rashes During Treatment with Alpelisib for Metastatic ER+, HER2- Breast Cancer with PIK3CA Mutations

RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer Scientific Title

Purpose

To study the ability of benralizumab to prevent rashes during treatment with alpelisib (Piqray®) PI3K inhibitor and hormone therapy.

Who is this for?

Postmenopausal women and men with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with PIK3CA mutations who are planning to receive hormone therapy. You must not have received more than 2 lines of hormone therapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Benralizumab, by injection, 1 time</li> </ul> with standard of care therapy: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), 3 times within 1 month, then monthly, or an aromatase inhibitor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Skin rash is a common side effect of alpelisib (Piqray®).</li> <li class="seamTextUnorderedListItem">Researchers think adding benralizumab to standard of care therapy may prevent rashes.</li> <li class="seamTextUnorderedListItem">Benralizumab is an immunotherapy that is used to treat diseases such as asthma. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, alpelisib (Piqray®), fulvestrant (Faslodex®), and aromatase inhibitors are standard of care therapies.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05966584' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a618002.html#:~:text=Benralizumab%20injection%20is%20used%20along,with%20their%20current%20asthma%20medication.' target='_blank'>MedlinePlus: Benralizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 4 visits within 1 year

PHASE: II

NCT ID: NCT06023576

Managing High Blood Pressure During Treatment for Women with Stage I-IV Breast Cancer

Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial Scientific Title

Purpose

To compare the safety and effects (good and bad) of 2 methods of managing high blood pressure during breast cancer treatment.

Who is this for?

Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer and high blood pressure who are planning to receive chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard doses of high blood pressure medication</li> <li class="seamTextUnorderedListItem">Dietary and lifestyle changes</li> <li class="seamTextUnorderedListItem">Echocardiograms, 3 times</li> <li class="seamTextUnorderedListItem">Exercise tests, 3 times</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Higher doses of high blood pressure medication</li> <li class="seamTextUnorderedListItem">Dietary and lifestyle changes</li> <li class="seamTextUnorderedListItem">Echocardiograms, 3 times</li> <li class="seamTextUnorderedListItem">Exercise tests, 3 times</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, such as high blood pressure, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">Dietary changes include limiting salt intake.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06023576' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lbbc.org/about-breast-cancer/side-effects/heart-health' target='_blank'>Living Beyond Breast Cancer: Heart Health</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 5 visits

PHASE: NA

NCT ID: NCT05590949

Studying Bone Changes in Post-Menopausal Women with Stage I-IV Breast Cancer After Treatment with Aromatase Inhibitor and Denosumab

Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation Scientific Title

Purpose

To gather information about changes in the bones after stopping treatment with an aromatase inhibitor and denosumab (Xgeva®).

Who is this for?

Postmenopausal women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have completed treatment with an aromatase Inhibitor before or within 6 months of completing at least 2 doses of denosumab (Xgeva®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physical exam, 5 visits within 2 years</li> <li class="seamTextUnorderedListItem">DEXA scan, 2 times within 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The physical exam will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work.</li> <li class="seamTextUnorderedListItem">Dual-energy X-ray absorptiometry (DEXA) scans use x-ray energy to measure bone density (thickness and strength of bones).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05590949' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/nceh/radiation/dexa-scan.html#:~:text=DEXA%20(dual%20x%2Dray%20absorptiometry,the%20hip%20and%20the%20spine.' target='_blank'>CDC: DEXA Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a610023.html' target='_blank'>MedlinePlus: Denosumab (Xgeva®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06144164

Managing Lymphedema After Lymph Node Surgery for Women with Stage I-III Breast Cancer

A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life Scientific Title

Purpose

To study the ability of a lymphedema prevention program to help lymph fluid drain out of the arm, prevent lymphedema, and improve quality of life.

Who is this for?

Women 18-75 years old with stage I, stage II, or stage III breast cancer who are planning to receive axillary lymph node dissection or sentinel lymph node biopsy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Immediate lymphatic reconstruction (ILR) during lymph node surgery</li> <li class="seamTextUnorderedListItem">Lymphatic massage, at home, 3 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Compression garments, daily for 3 months</li> <li class="seamTextUnorderedListItem">Arm measurements, up to 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lymphedema is the build up of fluid and abnormal swelling of the arm (in the case of axillary lymph node dissection or sentinel lymph node biopsy surgery).</li> <li class="seamTextUnorderedListItem">Lymphedema is caused by damage to the lymphatic system and inability to drain excess lymph fluid.</li> <li class="seamTextUnorderedListItem">Immediate Lymphatic Reconstruction (ILR) is a procedure to rebuild damaged lymphatic system.</li> <li class="seamTextUnorderedListItem">Lymphatic massage may help reduce swelling in your body.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06144164' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/about-your-immediate-lymphatic-reconstruction-ilr-procedure#:~:text=ILR%20is%20a%20procedure%20to,your%20axillary%20lymph%20node%20dissection.' target='_blank'>Memorial Sloan Kettering Cancer Center: About Your Immediate Lymphatic Reconstruction (ILR) Procedure</a> </li></ul>

NEAREST SITE: 2541 miles
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton,NJ

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05559164

Reducing Treatment-Related Heart Problems From Anti-HER2 Targeted Therapy

STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy Scientific Title

Purpose

To study whether atorvastatin (Lipitor®) reduces treatment delays or early discontinuations of anti-HER2 targeted therapy due to treatment-related heart problems.

Who is this for?

Women with stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who are planning to receive treatment with anti-HER2 targeted therapy. You must not currently be receiving any cholesterol drugs. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atorvastatin (Lipitor®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Questionnaires, 4 times within 1.25 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments including anti-HER2 targeted therapy can cause or increase the risk of heart problems, which is called cardiotoxicity. </li> <li class="seamTextUnorderedListItem">Atorvastatin (Lipitor®) is a cholesterol drug called a statin. Statins lower <q>bad cholesterol</q> which may reduce the risk of heart problems.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05559164' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statins/art-20045772' target='_blank'>Mayo Clinic: Statins Including Atorvastatin (Lipitor®)</a> </li></ul>

NEAREST SITE: 2561 miles
Memorial Sloan Kettering Bergen
Montvale,NJ

VISITS: 8 to 10 times for 2-3 years, then once a year for 2-3 years

PHASE: NA

NCT ID: NCT00823654

Measuring Hormone Levels to Study How Cancer Treatments & Inherited BRCA 1/2 Mutations Affect The Ovaries

Multi-Center Study of Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer and Lymphoma Scientific Title

Purpose

To study if a blood test that measures hormones can predict who will enter early menopause or develop fertility issues because of how chemotherapy and hormone therapy affect the ovaries; and to study the fertility and sexual health of women with inherited BRCA 1 or BRCA 2 mutations.

Who is this for?

Premenopausal women, 44 or younger, with DCIS or stage I, stage II, or stage III breast cancer planning to receive chemotherapy or tamoxifen. You may also enroll if you do not have breast cancer but have an inherited BRCA 1 or BRCA 2 mutation. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: Women with DCIS or stage I-III breast cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws, 8-10 times for 2-3 years, then once a year for 2-3 years (5 years total)</li> </ul> Group 2: Women with inherited BRCA mutations <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws, 5 times for the first year, then optional draws once a year for 4 years (5 years total)</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer treatments can affect the ovaries, which may cause early menopause or difficulty becoming pregnant. </li> <li class="seamTextUnorderedListItem">Ovarian functioning can be assessed by evaluating the blood levels of certain hormones the ovaries produce.</li> <li class="seamTextUnorderedListItem">Inherited BRCA 1/2 mutations may affect your ovaries.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT00823654' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.youngsurvival.org' target='_blank'>Young Survival Coalition</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.facingourrisk.org/index.php' target='_blank'>FORCE: Facing Our Risk of Cancer Empowered</a> </li></ul>

NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York,NY

VISITS: At least 4 visits within 6 months

PHASE: II

NCT ID: NCT05806138

Vericiguat for Treatment Related Heart Problems in People with Stage I-IV Breast Cancer

A Randomized Controlled Trial of the Soluble Guanylate Cyclase Stimulator Vericiguat in Patients With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction (ELEVATE) Scientific Title

Purpose

To study if adding vericiguat to standard of care treatment for heart problems is more effective than standard of care treatment for heart problems alone.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer and cancer treatment related heart problems. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vericiguat</li> <li class="seamTextUnorderedListItem">Standard of care treatment for heart problems</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care heart failure treatment</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">The addition of vericiguat to standard of care treatment for heart problems could help improve heart function, but it could also cause side effects.</li> <li class="seamTextUnorderedListItem">This study will help researchers find out whether this different treatment is better, the same as, or worse than the usual approach.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05806138' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a621014.html' target='_blank'>MedlinePlus: Vericiguat</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/heart-problems' target='_blank'>Breastcancer.org: Heart Problems</a> </li></ul>

NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center
New York,NY

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06037954

Improving Mental Health for Older Adults with Breast Cancer

Mental Health Care Initiation Intervention for Older Adults With Cancer Scientific Title

Purpose

To study the ability of the Open Door for Cancer (OD-C) approach to improve mental health for older adults with breast cancer.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who were diagnosed at age 65 or older and are currently receiving treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Open Door for Cancer (OD-C) approach, by phone or videoconference, 3 sessions within 1.5 months</li> </ul> Group 2: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mental health screening</li> <li class="seamTextUnorderedListItem">Referrals to support resources</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Open Door for Cancer (OD-C) approach includes the following: 1) Provide education about depression and treatment options; 2) Identify treatment preferences and a personal goal achievable with mental health care; 3) Assess barriers to starting treatment; 4) Referrals to additional support; 5) Address barriers to accessing care.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06037954' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/taking-care-of-mental-health/how-breast-cancer-affects-mental-health' target='_blank'>Breastcancer.org: How Breast Cancer Can Affect Mental Health</a> </li></ul>

NEAREST SITE: 2569 miles
Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center
New York,NY

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04973930

Tele-Interpersonal Psychotherapy or Medication for People with Depression and Breast Cancer

Pilot Randomized Feasibility Trial of Tele-Interpersonal Psychotherapy and Tele-Pharmacotherapy for Depression in Patients With Non-Metastatic Breast Cancer Scientific Title

Purpose

To study if tele-interpersonal psychotherapy (IPT) and/or medication decreases symptoms of depression.

Who is this for?

People with stage I, stage II, or stage III breast cancer and depression. You must not be currently receiving treatment for depression. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tele-interpersonal psychotherapy (IPT), by Zoom, once a week, for 3 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Venlafaxine (Effexor®) or escitalopram (Lexapro®), by mouth, daily for 3 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires blood tests and questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Interpersonal psychotherapy (IPT) is a type of therapy that focuses on the connection between upsetting life circumstances (such as diagnosis of breast cancer) and their effect on mood. It is known to lower symptoms of depression.</li> <li class="seamTextUnorderedListItem">If you are in Group 1, you will receive tele-IPT virtually through Zoom videoconferencing software. </li> <li class="seamTextUnorderedListItem">Venlafaxine (Effexor®) and escitalopram (Lexapro®) are two types of approved anti-depression treatments called serotonin reuptake inhibitors.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will meet with a doctor virtually to discuss your treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04973930' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/depression' target='_blank'>Breastcancer.org: Depression and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.psychologytoday.com/us/therapy-types/interpersonal-psychotherapy' target='_blank'>Psychology Today: Interpersonal Psychotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Types-of-Medication/Venlafaxine-(Effexor)' target='_blank'>National Alliance on Mental Illness: Venlafaxine (Effexor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Types-of-Medication/Escitalopram-(Lexapro)' target='_blank'>National Alliance on Mental Illness: Escitalopram (Lexapro®)</a> </li></ul>

NEAREST SITE: 2569 miles
Columbia University Medical Center
New York,NY

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05585788

Pain Medication Dispensing Device for People with Stage I-IV Breast Cancer Planning to Receive Surgery

Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery Scientific Title

Purpose

To study the ability of Addinex (ADX-27) pill dispensing system to safely store and dispense pain medication.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Addinex (ADX-27) pill dispensing system with mobile app, 3 months</li> <li class="seamTextUnorderedListItem">Phone interview, 1 time</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Addinex (ADX-27) is a password protected pill dispensing system. It allows for the return and disposal of unused opioids.</li> <li class="seamTextUnorderedListItem">Opioids are pain medications often given after surgery.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05585788' target='_blank'>ClinicalTrials.gov</a> </li></ul>

100

NEAREST SITE: 2569 miles
Columbia University Medical Center
New York,NY

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05496829

Improving Adherence to Hormone Therapy and Heart Disease Medication for People with Stage I-III Breast Cancer

IMPACT Trial: Intervention to iMProve AdherenCe Equitably Scientific Title

Purpose

To study whether a patient portal and smartphone reminder app help people adhere to treatment with hormone therapy and heart disease medication.

Who is this for?

People with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who are receiving treatment with hormone therapy and at least 1 medication for high blood pressure or high cholesterol to prevent heart disease. You must self-report that you do not take your medication as frequently as prescribed. You must receive care from a primary care provider or cardiologist within the New York Presbyterian Health System. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Access to patient portal with training from pharmacist</li> <li class="seamTextUnorderedListItem">Access to smartphone reminder app</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No access to patient portal or smartphone reminder app</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy is a common treatment for hormone receptor positive (HR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Antihypertensive medications are used to treat high blood pressure and statins are used to treat high cholesterol to prevent heart disease.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05496829' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/treatments/21811-antihypertensives' target='_blank'>Cleveland Clinic: Antihypertensive Medications</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/treatments/22282-statins' target='_blank'>Cleveland Clinic: Statins</a> </li></ul>

101

NEAREST SITE: 2573 miles
Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
Weston,FL

VISITS: 1 session every week, for 3 months (every other session is in person)

PHASE: NA

NCT ID: NCT04493034

The Effects of Art Therapy and Music Therapy on Quality of Life for People with Early Stage Breast Cancer

A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer Scientific Title

Purpose

To study whether art therapy and music therapy improve quality of life.

Who is this for?

People with DCIS, stage I, stage II or stage III breast cancer who are currently in treatment or who have completed treatment within the last 5 years. Full eligibility criteria

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What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 3 groups: Group 1: Art therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Art therapy session, weekly (1 week in person, 1 week home assignment), for 3 months</li> </ul> Group 2: Music therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Music therapy session, weekly (1 week in person, 1 week home assignment), for 3 months</li> </ul> Group 3: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will be given a list of support services</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers believe art therapy and music therapy may help reduce depression and anxiety in people with breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04493034' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/survivorship/complementary-therapies/art-therapy/' target='_blank'>Susan G. Komen: Art Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://bmccancer.biomedcentral.com/articles/10.1186/s12885-020-07380-5' target='_blank'>Journal Article: A Pilot Study of Improved Psychological Distress with Art Therapy in Patients with Cancer Undergoing Chemotherapy</a> </li></ul>

102

NEAREST SITE: 2573 miles
Cleveland Clinic Florida
Weston,FL

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05598879

Registry to Study Cardiovascular Health and Risk Factors in People with Breast Cancer

Global Cardio Oncology Registry Scientific Title

Purpose

To collect information on the diagnosis and treatment of cardiovascular health and risk factors in people with breast cancer.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer. Full eligibility criteria

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What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Collection of health information</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">This study uses clinical, laboratory, imaging, demographic, and socioeconomic information to study cardiovascular (heart and blood vessels) health and risk factors before, during, or after cancer treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05598879' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.heart.org/en/news/2020/02/19/what-women-need-to-know-about-breast-cancer-and-heart-disease' target='_blank'>American Heart Association: Breast Cancer and Heart Disease</a> </li></ul>

103

NEAREST SITE: 2591 miles
University of Miami
Miami,FL

VISITS: 2 visits within 1 month

PHASE: II

NCT ID: NCT05812924

Platelet-Rich Plasma for Vaginal and Urinary Health in Women During or After Breast Cancer Treatment

A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause Scientific Title

Purpose

To study the ability of platelet-rich plasma (PRP) injections to improve symptoms of genitourinary syndrome of menopause (GSM).

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or stage III breast cancer who are receiving treatment or have completed treatment. You must have abnormal urinary, genital, and sexual health symptoms. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Platelet-rich plasma (PRP), by injection into the vagina, 2 times</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genitourinary syndrome of menopause (GSM) refers to symptoms of abnormal urinary, genital, and sexual function. GSM can have a negative effect on a woman's quality of life.</li> <li class="seamTextUnorderedListItem">GSM can occur with natural menopause and in women who have received hormone therapy for breast cancer. Both natural menopause and hormone therapy greatly decrease the body's ability to make estrogen, and this can lead to GSM.</li> <li class="seamTextUnorderedListItem">Platelet-rich plasma (PRP) is obtained from your own blood and returned to your body to restore vaginal and urinary health.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05812924' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://consultqd.clevelandclinic.org/genitourinary-syndrome-of-menopause-in-breast-cancer-survivors/' target='_blank'>Cleveland Clinic: Genitourinary Syndrome of Menopause in Breast Cancer Survivors</a> </li><li class='seamTextUnorderedListItem'><a href='https://hf.org/healthcare-home/departments-services/womens-health/gynecology/prp-vaginal-rejuvenation#what-is-prp-therapy-' target='_blank'>Health First: Platelet-Rich Plasma for Vaginal and Urinary Health</a> </li></ul>

104

NEAREST SITE: 2691 miles
Massachusetts General Hospital
Boston,MA

VISITS: Coincides with standard follow-up care

PHASE: NA

NCT ID: NCT01521741

Impact of Lymphedema on Quality of Life After Breast Cancer

Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer. Scientific Title

Purpose

To determine how the symptoms and functional disability that accompany lymphedema can impact breast cancer survivors' quality of life.

Who is this for?

Women with breast cancer without axillary lymph node malignancy. Full eligibility criteria

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All participants will complete the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires and arm measurements</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer treatments can result in long-term, painful swelling of the arm and hand, a condition called lymphedema.</li> <li class="seamTextUnorderedListItem">To be eligible, participants must be planning to have surgery and receive follow-up care for breast cancer at Massachusetts General Hospital.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01521741' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/lymphedema' target='_blank'>BreastCancer.org: Lymphedema</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/side-effects/lymphedema/lymphedema-pdq#section/all' target='_blank'>National Cancer Institute: Lymphedema</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/lymphedema.html' target='_blank'>American Cancer Society: Lymphedema</a> </li></ul>

105

NEAREST SITE: 2693 miles
Dana Farber Cancer Institute
Boston,MA

VISITS: 4 visits over 8 months

PHASE: NA

NCT ID: NCT05327452

Exercise During Chemotherapy for Black and Hispanic People with Breast Cancer

Testing Home-based Exercise Strategies to Improve Exercise Participation and Cardiovascular Health in Underserved Minority Patients With Cancer Undergoing Chemotherapy: the THRIVE Study Scientific Title

Purpose

To determine whether an exercise intervention will affect physical activity levels and heart health in Black and Hispanic people with breast cancer.

Who is this for?

Black and Hispanic people newly diagnosed with stage I, stage II, or stage III breast cancer who are overweight/obese, engage in less than 90 minutes of exercise per week, and are planning to receive chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Virtually supervised home-based exercise, 3 times per week for 4 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Unsupervised home-based exercise, 3 times per week for 4 months</li> <li class="seamTextUnorderedListItem">Telehealth call with certified exercise trainer, 1 time per week for 4 months</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Home-based stretching, 3 times per week for 4 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cardiovascular and strength tests, 3 times within 8 months</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times within 8 months</li> </ul> All groups require 4 visits
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The home-based exercise interventions include aerobic and resistance exercises.</li> <li class="seamTextUnorderedListItem">If you are in Group 1, the virtual supervision will occur via Zoom.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05327452' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/exercise' target='_blank'>Breastcancer.org: Exercise</a> </li></ul>

106

NEAREST SITE: 2693 miles
Dana Farber Cancer Institute
Boston,MA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04379414

YES Portal for Monitoring Symptoms and Providing Support for Women Ages 18-39 with Breast Cancer

Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Newly Diagnosed/Metastatic Intervention Scientific Title

Purpose

To study the ability of the web-based YES portal to monitor cancer symptoms and provide support and educational resources.

Who is this for?

Women newly diagnosed with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer between the ages of 18-39 years who are planning to receive treatment at Dana-Farber Cancer Institute. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Access to YES portal, weekly for 3 months, then monthly</li> <li class="seamTextUnorderedListItem">Surveys, every 6 months for 3 years, then yearly for 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Young, Empowered, and Strong (YES) portal is a web-based portal designed to help monitor cancer-related issues and to share self-management information, resources, and potential research opportunities.</li> <li class="seamTextUnorderedListItem">The portal is also designed to create a community among participants through the yeschat.org discussion board.</li> <li class="seamTextUnorderedListItem">The portal can be accessed by smartphone, tablet, or laptop/desktop.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04379414' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials2/detail/20-124/' target='_blank'>Dana-Farber Cancer Institute Trial Information Page: YES Portal</a> </li><li class='seamTextUnorderedListItem'><a href='https://youngandstrong.dana-farber.org/' target='_blank'>Dana-Farber Cancer Institute: Young and Strong</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/CCI.21.00067' target='_blank'>Abstract: YES Portal</a> </li></ul>

107

NEAREST SITE: 2693 miles
Massachusetts General Hospital
Boston,MA

VISITS: 1 visit every 3 months up to 5 years

PHASE: NA

NCT ID: NCT05142800

Screening Women with Breast Cancer for Edema and Lymphedema During Targeted Therapy

Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer Scientific Title

Purpose

To study the onset of edema (swelling) and breast cancer-related lymphedema in women with breast cancer.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving targeted therapy after surgery at Massachusetts General Hospital Breast Cancer Center. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Informational brochure about lymphedema risk</li> <li class="seamTextUnorderedListItem">Lymphedema screening program card</li> <li class="seamTextUnorderedListItem">Measurement of arm volume with perometer and SOZO device, every 3 months up to 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Edema is swelling of body tissues due to excess fluid.</li> <li class="seamTextUnorderedListItem">Lymphedema is abnormal swelling that occurs following damage to the lymphatic system, which can happen after breast cancer surgery.</li> <li class="seamTextUnorderedListItem">The perometer uses light sensors to calculate the length and volume of your arms.</li> <li class="seamTextUnorderedListItem">The SOZO device measures the amount of fluid in your arm(s).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05142800' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/lymphedema' target='_blank'>Breastcancer.org: Lymphedema</a> </li></ul>

108

NEAREST SITE: 2693 miles
Dana Farber Cancer Institute
Boston,MA

VISITS: 1-2 visits per week for 3 months

PHASE: NA

NCT ID: NCT05528263

Acupuncture to Prevent Chemotherapy-Induced Peripheral Neuropathy for People with Stage I-III Breast Cancer

Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture, A Randomized Controlled Trial (PACT Trial) Scientific Title

Purpose

To study the ability of acupuncture to prevent chemotherapy-induced peripheral neuropathy (CIPN).

Who is this for?

People with stage I, stage II, or stage III breast cancer who are planning to receive chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Acupuncture, 1-2 times per week for 3 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nature scenery video with relaxation exercise guide, 1-2 times per week for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy-induced peripheral neuropathy (CIPN) is nerve pain in your hands and feet as a side effect of chemotherapy.</li> <li class="seamTextUnorderedListItem">Neuropathy is pain from nerve damage.</li> <li class="seamTextUnorderedListItem">Acupuncture is a form of complementary medicine in which thin needles are inserted into the body.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05528263' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/complementary-therapy/types/acupuncture#:~:text=Research%20on%20acupuncture%20in%20people%20with%20breast%20cancer%20and%20other%20types%20of%20cancer,-Advertisement&text=Much%20research%20is%20being%20done,nausea%2C' target='_blank'>Breastcancer.org: Acupuncture</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/neuropathy' target='_blank'>Breastcancer.org: Neuropathy</a> </li></ul>

109

NEAREST SITE: 2693 miles
Brigham and Women's Hospital
Boston,MA

VISITS: 1 visit every 1-3 weeks

PHASE: II

NCT ID: NCT04986579

Scalp Cooling to Prevent Hair Loss During Chemotherapy for People With Metastatic Breast Cancer

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer Scientific Title

Purpose

To study the ability of the Paxman Scalp Cooling System to prevent hair loss during treatment with chemotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer that are planning to receive chemotherapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: Chemotherapy with Scalp Cooling <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paxman Scalp Cooling System, every 3 weeks</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or trastuzumab deruxtecan (Enhertu®), by IV, every 1-3 weeks</li> </ul> Group 2: Chemotherapy without Scalp Cooling <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or trastuzumab deruxtecan (Enhertu®), by IV, every 1-3 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Paxman Scalp Cooling System is FDA-approved for preventing hair loss for people undergoing chemotherapy.</li> <li class="seamTextUnorderedListItem">The Paxman Scalp Cooling System has not been studied to look at its ability to prevent hair loss in patients specifically receiving eribulin (Halaven®), sacituzumab govitecan (Trodelvy®), or trastuzumab deruxtecan (Enhertu®).</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a HER2-targeted antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a Trop-2-targeted antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04986579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://coldcap.com//?lang=us' target='_blank'>Paxman: Paxman Scalp Cooling System</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/managing-hair-loss-scalp-cooling' target='_blank'>Memorial Sloan Kettering Cancer Center: Scalp Cooling</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (Enhertu®)</a> </li></ul>

110

NEAREST SITE: 2693 miles
Beth Israel Deaconess Medical Center
Boston,MA

VISITS: Number of visits unavailable, over 1 year

PHASE: NA

NCT ID: NCT02666378

Detecting Treatment-Related Cardiotoxicity in HER2 Positive Breast Cancer

Imaging Markers of Subclinical Cardiotoxicity in Breast Cancer Scientific Title

Purpose

To determine whether Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram (ECHO) tests can be used to identify early signs of heart problems that can be caused by Doxil and Herceptin.

Who is this for?

Women with HER2 positive breast cancer who are going to be treated with doxorubicin (Doxil®) and trastuzumab (Herceptin®) after surgery. Full eligibility criteria

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You will undergo the following before treatment with chemotherapy and at predetermined times during and after treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI (Cardiac Magnetic Resonance Imaging, CMR)</li> <li class="seamTextUnorderedListItem">Ultrasound (Echocardiogram, ECHO)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is investigating whether Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram (ECHO) tests can be used to identify early signs of heart problems that can be caused by Doxil and Herceptin.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02666378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/tx-w-herceptin-needs-heart-monitoring' target='_blank'>Breastcancer.org: Women Treated With Herceptin Need Heart Monitoring</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/heart-meds-reduce-herceptin-cardiac-damage' target='_blank'>Breastcancer.org: Medicine for Herceptin Related Heart Damage</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20111005' target='_blank'>Breastcancer.org: Herceptin Related Heart Damage</a> </li></ul>

111

NEAREST SITE: 2693 miles
Massachusetts General Hospital Cancer Center
Boston,MA

VISITS: 9 visits within 1 year

PHASE: NA

NCT ID: NCT05912231

Comparing Two Different Types of Radiation to Reduce Heart Problems for Stage II-III Breast Cancer

Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue Scientific Title

Purpose

To compare the effects on the heart of proton beam radiation therapy (PBT) and standard photon radiation therapy (XRT).

Who is this for?

Women with stage II or stage III breast cancer who are planning to receive radiation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Accelerated Proton Beam Radiation Therapy (PBT), daily for 5 days</li> <li class="seamTextUnorderedListItem">MRI scan, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Questionnaires, 2 times within 1 year</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Accelerated Photon Radiation Therapy (XRT), daily for 5 days</li> <li class="seamTextUnorderedListItem">MRI scan, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Questionnaires, 2 times within 1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Because the heart is on the left side of the chest, radiation to treat cancer, especially when cancer is in the left breast, may increase the chance of heart problems.</li> <li class="seamTextUnorderedListItem">Photon Radiation Therapy (XRT) is standard radiation therapy using high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Proton Beam Radiation Therapy (PBT) uses protons (instead of x-rays) to treat the tumor.</li> <li class="seamTextUnorderedListItem">Because the proton beam can be more directly targeted to the tumor, proton therapy may result in fewer side effects than x-ray radiation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05912231' target='_blank'>ClinicalTrials.gov</a> </li></ul>

112

NEAREST SITE: 2694 miles
BU School of Medicine
Boston,MA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05595213

Wrist Cooling for Hot Flashes for Women with Breast Cancer

Double Blind Randomized Pilot Evaluation of the Response Profiles of Wrist Cooling Devices for Men With Prostate Cancer and Women With Breast Cancer on Hormone Deprivation Therapy Who Suffer From Moderate and or Severe Hot Flashes Scientific Title

Purpose

To study if a wrist cooling device helps reduce the severity of hot flashes for women with breast cancer.

Who is this for?

Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving hormone therapy and experience at least 2 hot flashes per day. Full eligibility criteria

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You will complete the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Wear wrist cooling device, 1.5 months</li> <li class="seamTextUnorderedListItem">Complete hot flash diary, 1.5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The wrist cooling device is worn like a watch. Pressing the button activates the cooling function to begin to cool the wrist skin temperature.</li> <li class="seamTextUnorderedListItem">You will receive a wrist cooling device that cools up to 5 minutes or up to 5 seconds.</li> <li class="seamTextUnorderedListItem">In the hot flash diary, you will be asked to document each hot flash experience and if you used the wrist cooling device.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05595213' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/ency/patientinstructions/000826.htm' target='_blank'>MedlinePlus: Cancer Treatment and Hot Flashes</a> </li></ul>

113

NEAREST SITE: 2694 miles
Massachusetts General Hospital Cancer Center
Boston,MA

VISITS: 5 visits every week up to 1.5 months

PHASE: NA

NCT ID: NCT05607017

Losartan to Prevent Heart Problems from Radiation for Stage I-III Breast Cancer

The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure Scientific Title

Purpose

To study if losartan (Cozaar®) helps prevent heart problems caused by radiation.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who are planning to receive radiation. Your breast cancer must be on the left side of your body. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation, 5 times each week, up to 1.5 months</li> <li class="seamTextUnorderedListItem">Losartan (Cozaar®), by mouth, daily, up to 6 months</li> <li class="seamTextUnorderedListItem">MRI scan, 1 time</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">Because the heart is located on the left side of the chest, radiation to cancer in the left breast may increase the chance of heart problems.</li> <li class="seamTextUnorderedListItem">Losartan (Cozaar®) is FDA approved to treat high blood pressure and heart failure. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05607017' target='_blank'>ClinicalTrials.gov</a> </li></ul>

114

NEAREST SITE: 2698 miles
Mass General/North Shore Center for Outpatient Care
Danvers,MA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05837598

Improving Cancer Care and Mental Health Care for People with Newly Diagnosed Stage I-IV Breast Cancer

Adapting the Tumor Board Model for Mental Illness and Cancer: A Single Arm Pilot Trial Scientific Title

Purpose

To study whether a virtual tumor board can improve cancer care and mental health care.

Who is this for?

People with newly diagnosed stage I, stage II, stage III, or stage IV (metastatic) breast cancer. You must also have one of the following mental illnesses: schizophrenia, bipolar disorder, or major depressive disorder. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Assessment of your needs, values, mental health symptoms, and barriers to care</li> <li class="seamTextUnorderedListItem">Recommendations from the virtual tumor board to help you receive the care you need</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A tumor board is a group of doctors and other health care providers that meets regularly at the hospital to discuss cancer cases and share knowledge.</li> <li class="seamTextUnorderedListItem">A virtual cancer and mental health tumor board may help people access the cancer and mental health care they need.</li> <li class="seamTextUnorderedListItem">The tumor board will notify your doctor with treatment and care recommendations.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05837598' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/blog/2017-07/what-tumor-board-expert-qa' target='_blank'>ASCO: What is a Tumor Board?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mhanational.org/cancer-and-mental-health' target='_blank'>Mental Health America: Cancer and Mental Health</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/lung-cancer-treating-mental-health-longer-survival' target='_blank'>National Cancer Institute: Study Links Mental Health Treatment to Improved Cancer Survival</a> </li></ul>

115

No Travel Required

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04379570

Telephone and Online Support for Women with Stage I-III, HR+, HER2- Breast Cancer Taking Anti-Estrogen Therapy

Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions Scientific Title

Purpose

To study if different types of telephone and online education can help women take their anti-estrogen therapy.

Who is this for?

Women with stage I, stage II or stage III hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have started taking anti-estrogen therapy within the last 6 months or intend to start taking it within the next 6 weeks. Full eligibility criteria

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You will be randomly assigned to 1 of 4 groups and receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online education about anti-estrogen therapy, 1 time</li> <li class="seamTextUnorderedListItem">Text message reminders to take anti-estrogen therapy, daily, for 9 months</li> <li class="seamTextUnorderedListItem">Test messages asking about side effects and taking anti-estrogen therapy, monthly, for 9 months</li> <li class="seamTextUnorderedListItem">Questionnaires </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online education about anti-estrogen therapy, 1 time</li> <li class="seamTextUnorderedListItem">Motivational telephone therapy sessions, 5 times, over 9 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online education about anti-estrogen therapy, 1 time</li> <li class="seamTextUnorderedListItem">Text message reminders to take anti-estrogen therapy, daily, for 9 months</li> <li class="seamTextUnorderedListItem">Test messages asking about side effects and taking anti-estrogen therapy, monthly, for 9 months</li> <li class="seamTextUnorderedListItem">Motivational telephone therapy sessions, 5 times, over 9 months</li> <li class="seamTextUnorderedListItem">Questionnaires </li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online education about anti-estrogen therapy, 1 time</li> <li class="seamTextUnorderedListItem">Optional online education about healthy living</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is studying whether text messaging, online education, and telephone support can help women take their anti-estrogen therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04379570' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/expect' target='_blank'>Breastcancer.org: Hormonal Therapy, What to Expect</a> </li></ul>

116

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT04806724

Improving Sexual Health for People with Breast Cancer and Their Partners

Opening the Conversation for Couples With Reproductive Health Concerns Scientific Title

Purpose

To evaluate an intervention designed to help young couples cope with and communicate about cancer-related reproductive and sexual health concerns.

Who is this for?

People 18-44 years old with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who were diagnosed between 6 months and 5 years ago. You must have a partner who is willing to participate. Full eligibility criteria

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You and your partner will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Virtual education and skills training addressing cancer-related reproductive and sexual health concerns, weekly for 5 weeks, 1.5 hours each</li> <li class="seamTextUnorderedListItem">Home activities between sessions</li> <li class="seamTextUnorderedListItem">Questionnaires, 2 times in 4 months</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Virtual education and skills training addressing cancer-related concerns, weekly for 4 weeks, 1.5 hours each</li> <li class="seamTextUnorderedListItem">Home activities between sessions</li> <li class="seamTextUnorderedListItem">Questionnaires, 2 times in 4 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Young adults with breast cancer face a number of challenges, including interrupted life plans and negative effects of cancer and treatment on their reproductive health, sexual function, and ability to have children.</li> <li class="seamTextUnorderedListItem">When left unaddressed, these problems can lead to poor mental health and quality of life.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04806724' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://health.oregonstate.edu/research/programs/tact/oc' target='_blank'>Oregon State University: Opening the Conversation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lbbc.org/about-breast-cancer/family-relationships/sex-and-intimacy?gclid=Cj0KCQjwjryjBhD0ARIsAMLvnF9QCfoHExQGyLtztxRugVKOdyz7EhUqQUeInby37mQ444LjqxHoI1waAmYlEALw_wcB' target='_blank'>Living Beyond Breast Cancer: Sex and Intimacy</a> </li></ul>

117

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT05715255

Counseling by Phone to Help Manage Side Effects of Immunotherapy for Stage II-IV Breast Cancer

Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors Scientific Title

Purpose

To study whether telephone-based counseling will improve your ability to manage immunotherapy side effects.

Who is this for?

People with stage II, stage III, or stage IV (metastatic) breast cancer who have begun treatment with an immune checkpoint inhibitor within the past 3 months. You must be experiencing at least mild psychological distress. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Counseling, by phone call, weekly</li> <li class="seamTextUnorderedListItem">Handbook about managing side effects</li> <li class="seamTextUnorderedListItem">Assessment of side effects, weekly</li> <li class="seamTextUnorderedListItem">Interviews, 2 times within 4 months</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Assessment of side effects, weekly</li> <li class="seamTextUnorderedListItem">Interviews, 2 times within 4 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Side effects from immunotherapy are common.</li> <li class="seamTextUnorderedListItem">The ability to manage the side effects you experience from immunotherapy may reduce your distress, prevent treatment interruption, and lead to fewer visits to your doctor.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05715255' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/types/breast-cancer/treatment/immunotherapy.html#:~:text=Possible%20side%20effects%20of%20immune,reaction%20while%20getting%20these%20drugs.' target='_blank'>American Cancer Society: Immune Checkpoint Inhibitors for Breast Cancer and Their Side Effects</a> </li></ul>

118

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT05612100

Studying Alopecia During Hormone Therapy in Women with Breast Cancer

Endocrine Therapy-Induced Alopecia Natural History Evaluation Among Female Breast Cancer Survivors Scientific Title

Purpose

To study the incidence, timing, duration, and severity of alopecia (hair loss) during hormone therapy.

Who is this for?

Women with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who are receiving or planning to receive hormone therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires, every 3 months for 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">While alopecia (hair loss) is a well-known side effect of many chemotherapy drugs, it has also been reported by women undergoing hormone therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05612100' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/hair-loss' target='_blank'>Breastcancer.org: Alopecia/Hair Loss</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

119

No Travel Required

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05444231

Online Education to Improve Brain Health After Treatment for People with Stage I-III Breast Cancer

BrainHealth in Breast Cancer Survivors Scientific Title

Purpose

To determine if online education called Strategic Memory Advanced Reasoning Training (SMART) can improve brain health.

Who is this for?

Women 28-80 years old with stage I, stage II, or stage III breast cancer who have completed treatment. If you received chemotherapy, you must have completed chemotherapy between 6 months and 5 years ago. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Immediately Start Education <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online education starting immediately, weekly for 9 months</li> <li class="seamTextUnorderedListItem">Group coaching calls, 5 times within 9 months</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times within 9 months</li> </ul> Group 2: Delayed Start Education <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online education starting 3 months after joining trial, weekly for 9 months</li> <li class="seamTextUnorderedListItem">Group coaching calls, 5 times within 9 months</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times within 9 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The online education is called Strategic Memory Advanced Reasoning Training (SMART) and takes 15 minutes each week to complete.</li> <li class="seamTextUnorderedListItem">The online education includes: 1) Strategies to more effectively process information and manage stress, 2) Scientific information about the importance of sleep and actionable tips on how to get better sleep, and 3) Quick, interactive activities that reinforce information learned in online modules</li> <li class="seamTextUnorderedListItem">Online modules also build awareness of how daily habits (sleep, nutrition, exercise, social interactions, etc.) may impact performance for better or worse.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05444231' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/side-effects/memory#:~:text=Cancer%20treatments%20such%20as%20chemotherapy,during%20or%20after%20cancer%20treatment.' target='_blank'>National Cancer Institute: Memory and Concentration Problems and Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/side-effects/fatigue-and-insomnia/' target='_blank'>Susan G. Komen: Sleep and Cancer Treatment</a> </li></ul>

120

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT06085313

Online Pain and Depression Support Program for Asian Women with Stage I-IV Breast Cancer

Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors (CAI) Scientific Title

Purpose

To study if an online pain and depression management program can support Asian women with breast cancer.

Who is this for?

Chinese, Korean, or Japanese women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who were diagnosed within the last 5 years and are experiencing pain and depression. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized information and support program, online</li> <li class="seamTextUnorderedListItem">Fitbit</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General information and support program, online</li> <li class="seamTextUnorderedListItem">Fitbit</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The pain and depression management program provides web-based information, coaching, and support that is culturally tailored to Asian American women with breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is also available in Mandarin (simplified or traditional), Korean, and Japanese.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06085313' target='_blank'>ClinicalTrials.gov</a> </li></ul>

121

No Travel Required

VISITS: No visits required

PHASE: III

NCT ID: NCT05703178

Web-Based Coping Skills Training to Decrease Pain from Hormone Therapy

Web-based Pain Coping Skills Training to Improve Pain and Poor Adherence Caused by Aromatase Inhibitor-Associated Arthralgia In Breast Cancer Survivors (SKIP-Arthralgia): A Randomized Controlled Trial Scientific Title

Purpose

To study if an online pain coping skills training program reduces the severity and effects of pain from treatment with aromatase inhibitors.

Who is this for?

Postmenopausal women with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who have completed treatment. You must be taking an aromatase inhibitor and experience pain in your joints, bones, and/or muscles. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online pain coping skills training program, weekly for 2-3 months</li> <li class="seamTextUnorderedListItem">Educational booklet about aromatase inhibitors and side effects</li> <li class="seamTextUnorderedListItem">Electronic pill bottle to track use of aromatase inhibitor medication</li> <li class="seamTextUnorderedListItem">Continue usual care</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Educational booklet about aromatase inhibitors and side effects</li> <li class="seamTextUnorderedListItem">Electronic pill bottle to track use of aromatase inhibitor medication</li> <li class="seamTextUnorderedListItem">Continue usual care</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires, 4 times within 9-10 months</li> <li class="seamTextUnorderedListItem">Virtual visits, 3 times within 1 month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy that block some production of estrogen that helps cancer grow. Approved aromatase inhibitors include anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Arthralgia is pain in the joints, bones, and/or muscles and is a common side effect of aromatase inhibitors.</li> <li class="seamTextUnorderedListItem">The online pain coping skills training is an interactive, web-based program that teaches cognitive and behavioral skills to reduce pain and pain-related interference with daily activities. The program includes 8 sessions that are 35-45 minutes each. You will complete about 1 session per week.</li> <li class="seamTextUnorderedListItem">If you do not have a device capable of accessing the program, you will be loaned a tablet computer for the study.</li> <li class="seamTextUnorderedListItem">Benefits of the online pain coping skills training may include reduced severity of pain, improvements in quality of life, and improved adherence to aromatase inhibitor medication. The training may also increase your confidence in managing your pain and reduce unhelpful thinking patterns about pain.</li> <li class="seamTextUnorderedListItem">The educational booklet contains information about aromatase inhibitors, side effects including arthralgia, methods for managing arthralgia, and tips for talking with doctors about arthralgia and other side effects.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05703178' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.scholars.northwestern.edu/en/projects/web-based-pain-coping-skills-training-to-improve-pain-and-poor-ad' target='_blank'>Northwestern University: Pain Coping Skills Training</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/hormone-therapy/aromatase-inhibitors/side-effects/' target='_blank'>Susan G Komen: Side Effects of Aromatase Inhibitors</a> </li></ul>

122

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT05452681

Improving Quality of Life of Young Black Women After Treatment

Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors Scientific Title

Purpose

To compare how Y-AMBIENT education sessions and follow up phone calls improve quality of life after breast cancer treatment.

Who is this for?

Black or African American women ages 18 to 44 years old with stage I, stage II, or stage III breast cancer who have completed treatment with chemotherapy and/or radiation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Y-AMBIENT education sessions, 3 times within 4 months</li> <li class="seamTextUnorderedListItem">Y-AMBIENT follow up phone calls, 3 times within 4 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Education sessions, 3 times within 4 months</li> <li class="seamTextUnorderedListItem">Follow up phone calls, 3 times within 4 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Y-AMBIENT is telephone-based intervention with education sessions designed to improve quality of life. Session 1, titled <q>My Self, My Soul,</q> covers topics related to spiritual growth and finding meaning in illness. Session 2, titled <q>My Body,</q> covers topics related to breast changes, aches/pains, fatigue, and weight changes. Session 3, titled <q>My Mind and My Relationships,</q> covers topics related to anxiety, fear, and relationships with others.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, education sessions include a culturally-targeted cookbook and a guide to grocery shopping smart.</li> <li class="seamTextUnorderedListItem">For both groups, all sessions will take approximately one hour, and follow-up phone calls will last about 20 minutes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05452681' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/survivorship/health-concerns/quality-of-life/#:~:text=Quality%20of%20life%20after%20treatment,even%20years%20after%20treatment%20ends.' target='_blank'>Susan G. Komen: Quality of Life After Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/pcd/issues/2016/16_0096.htm' target='_blank'>Centers for Disease Control and Prevention: Quality of Life of Black Breast Cancer Survivors</a> </li></ul>

123

No Travel Required

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05243056

Improving Quality of Life for Young African American Women with Stage I-III Breast Cancer

Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment Scientific Title

Purpose

To study if Y-AMBIENT education sessions help African American women with breast cancer manage daily life.

Who is this for?

Black or African American women 18-44 years old with stage I, stage II, or stage III breast cancer who are receiving chemotherapy and/or radiation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Y-AMBIENT education sessions, by phone, 3 sessions within 4 months</li> <li class="seamTextUnorderedListItem">Phone calls discussing treatment and concerns, 3 times within 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Enhanced Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phone calls discussing treatment and concerns, 3 times within 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Y-AMBIENT is a telephone-based intervention that includes three themed education sessions with three follow-up sessions, written materials, and videos.</li> <li class="seamTextUnorderedListItem">The Y-AMBIENT sessions are 1 hour each and may improve quality of life and other health-related outcomes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05243056' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life' target='_blank'>Breastcancer.org: Managing Life With Cancer</a> </li></ul>

124

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT06180460

Telehealth CALM Therapy for People with Metastatic Breast Cancer with Brain Metastasis

Managing Distress in Malignant Brain Cancer - Phase IIc RCT Scientific Title

Purpose

To study if telehealth CALM therapy decreases distress.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are experiencing depression or anxiety. Full eligibility criteria

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What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Telehealth CALM therapy, 6 sessions over 3-6 months</li> </ul> Group 2: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">List of resources for distress</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Managing Cancer and Living Meaningfully (CALM) sessions address four topics: 1) Symptom management and communication with healthcare providers, 2) Changes in personal relationships, 3) Sense of meaning and purpose, and 4) The future, hope and mortality.</li> <li class="seamTextUnorderedListItem">If you are in Group 1, you will receive CALM therapy virtually through telehealth.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06180460' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

125

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT05226078

Therapy for Fatigue and Sleep Problems for Women with Stage I-III Breast Cancer

The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients Scientific Title

Purpose

To study the ability of therapy to reduce fatigue and sleep problems in women with breast cancer.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who plan to receive, are receiving, or have received radiation. You must be experiencing fatigue and sleep problems. Full eligibility criteria

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What's involved?
What's being studied?
How can I learn more?

You will receive the following <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive behavioral therapy (CBT), by telehealth, weekly for 1-3 months</li> <li class="seamTextUnorderedListItem">Sleep diary, daily</li> <li class="seamTextUnorderedListItem">Questionnaires, weekly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fatigue and sleep problems (insomnia) are common in people with cancer.</li> <li class="seamTextUnorderedListItem">Cognitive behavioral therapy (CBT) is a type of therapy that focuses on the relationship between thoughts, feelings, and behaviors.</li> <li class="seamTextUnorderedListItem">All therapy appointments will be held by telehealth (virtually).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05226078' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/side-effects/fatigue-and-insomnia/#:~:text=Some%20treatments%20may%20cause%20fatigue,time%20%5B279%2D280%5D.' target='_blank'>Susan G. Komen: Fatigue and Insomnia</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/diseases-conditions/insomnia/in-depth/insomnia-treatment/art-20046677' target='_blank'>Mayo Clinic: Cognitive Behavioral Therapy (CBT) for Insomnia</a> </li></ul>

126

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT05053230

Integrative Medicine at Home Program for People With Stage I-IV Breast Cancer

Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE) Scientific Title

Purpose

To find out whether the Integrative Medicine at Home program can help reduce symptoms and improve treatment satisfaction.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are currently receiving treatment. Full eligibility criteria

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Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Integrative Medicine at Home program, 3 months</li> </ul> Group 2: Enhanced Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Integrative medicine handout</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Integrative Medicine at Home program offers virtual (online rather than in-person) group classes focusing on mind-body practice.</li> <li class="seamTextUnorderedListItem">Mind-body practice is a health practice that combines mental focus, controlled breathing, and body movements to help relax the body and mind and reduce symptoms such as tiredness, pain, or insomnia.</li> <li class="seamTextUnorderedListItem">The classes will be led by an Integrative Medicine Service (IMS) clinical therapist using Zoom video conferencing platform.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will be given a handout to encourage you to visit Memorial Sloan Kettering's Integrative Medicine website to access pre-recorded, on-demand meditation videos and audios.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05053230' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine' target='_blank'>Memorial Sloan Kettering Cancer Center: Integrative Medicine</a> </li></ul>