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Supportive

Dose Adjustments to Reduce Afinitor-Induced Mouth Sores

Phase II Evaluation of Real-Time, Pharmacokinetically Guided Everolimus in Patients With Hormone Receptor Positive Breast Cancer, Pancreatic Neuroendocrine Tumors (PNET), and Renal Cell Carcinoma (NCT02273752)

Summary

Everolimus (Afinitor®) is a new type of targeted therapy called an mTOR inhibitor. Mouth sores (stomatitis)) are a common side effect of Afinitor. In this study, postmenopausal women with ER+, HER2- breast cancer (and other solid tumors) taking Afinitor will have their blood analyzed weekly. The researchers will use that information to adjust the dose of Afinitor when necessary to reduce mouth sores while maintaining the drug's effectiveness. To be eligible, participants must have already been treated with letrozole (Femara®) or anastrozole (Arimidex®).
This is a Phase II trial

Safety of HER2-Targeted Therapies in Patients with Mildly Decreased Heart Function

SAFE-HEaRt: A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients With HER2 Positive Breast Cancer and Reduced Left Ventricular Function (NCT01904903)

Summary

The HER2 targeted therapies—trastuzumab (Herceptin®), pertuzumab (Perjeta®) and ado-trastuzumab emtansine (Kadycla®)—may cause heart problems in some patients. These drugs are currently approved only for patients with normal heart functioning. It may be possible for HER2+ patients with mildly decreased heart function to also safely use a HER2-targeted therapy. This study is looking at the safety of giving a HER2–targeted therapy to patients with mildly decreased heart function when these patients are evaluated regularly by a cardiologist and take heart medication. To be eligible, participants must have HER2–positive breast cancer and mildly decreased heart function.
This is a Phase II trial

Exercise & Weight Management for People at High Risk for Triple-Negative Breast Cancer

Pilot Tests to Optimize the Delivery of Energy Balance Interventions (NCT02194387)

Summary

Previous studies have suggested that risk for triple-negative breast cancer (TNBC) is higher in people who are overweight and not physically active. Researchers are trying to determine what types of programs can help people lose weight and exercise more. Fitbit® is a small, wearable physical activity tracker that is designed to help with exercise and weight management. Telephone coaching, text messages, social networking, and self-monitoring can also help people trying to exercise more and lose weight. This study is looking at which combination of coaching, texting, and social networking is most effective in helping women at high-risk for breast cancer exercise more and lose weight. To be eligible, participants must have a BMI ≥25. They must also know they carry a BRCA mutation or be a family member of a breast cancer survivor.

An Online Weight Loss & Exercise Program for Survivors

An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program (NCT01728506)

Summary

Women who are overweight when diagnosed with breast cancer or who gain weight during their breast cancer treatment are more likely to have their breast cancer come back (recurrence). Women who exercise at least three hours a week seem to have less chance of their cancer coming back. This study is looking at whether a 6-month online diet and exercise program can help breast cancer survivors lose weight. Participants take part in on-line "chats" about healthy food choices and in an aerobic activity (typically walking). To be eligible, participants must have received their care at the Vermont Cancer Center or the Norris Cotton Cancer Center at Dartmouth University or the University of Massachusetts Cancer Center.

  • Participation TimeWeekly online chats
  • No Visits Required for this TrialNo travel required 

Helping Parents Talk to Their School-Age Children About Cancer

Enhancing Connections Telephone Program: A Cancer Education Program for Parents (NCT02129049)

Summary

A cancer diagnosis can cause emotional distress in both parents and children. But it can be difficult for parents to talk to their children about their cancer or support their children while undergoing cancer treatment. Studies have found that the Enhancing Connections Program, an in-person educational program, can decrease parents' depression and anxiety; improve parenting quality, parenting skills and confidence; and enhance the child's behavioral-emotional adjustment. Providing this education program by telephone may help parents talk with their school-age children about their cancer. This trial is investigating the effectiveness of using the Enhancing Connections Program by telephone to improve communication between patients with early stage cancer and their children. To be eligible, participants must have had a diagnosis of stage 0-III breast cancer within the last seven months.

  • Participation Time5 telephone sessions over 3 months
  • No Visits Required for this TrialNo travel required 

Work-Related Cognitive Problems Experienced by Breast Cancer Survivors

The Relationship Between Biopsychosocial Functioning and Work-Related Cognitive Limitation Among Employed Breast Cancer Survivors: Case Control Study. (NCT02303145)

Summary

Cognitive functioning includes a person's ability to remember, process thoughts, pay attention, solve problems and concentrate. Cancer therapies can cause cognitive functioning problems that can impact breast cancer survivors' general well-being. Lumosity is an online tool that allows anyone to increase their "brain fitness." This study is looking at the relationship between the cognitive problems breast cancer survivors experience at work, the breast cancer treatments they have had, and other emotional or psychological problems, such as depression, anxiety, pain, fatigue, and sleep disturbances, they may be experiencing. In this study, psychological and physical well-being will be self-reported through web-based questionnaires and cognitive functioning will be measured using the Lumosity Brain Performance Test (BPT). To be eligible, breast cancer patients must have completed treatment (hormone therapy is ok), be working part- or full-time, and have internet access. This trial is also enrolling healthy women who have not had breast cancer to be part of a comparison group.

  • Participation TimeOnline questionnaire
  • No Visits Required for this TrialNo travel required 

Preventing Sexual Dysfunction With Aromatase Inhibitors

Preventing Sexual Dysfunction in Women on Aromatase Inhibitors (NCT01603303)

Summary

Aromatase inhibitors (AIs) are used to treat hormone-sensitive breast cancer in post-menopausal women. A common side effect of the AIs is vaginal dryness and pain during sexual activity. Two new vaginal moisturizers are now available. The researchers are interested in seeing if one or both of these moisturizers can reduce dryness and pain during sexual activity in women being treated with an AI. The researchers also want to see if preventing these side effects will get more women to keep taking their AI. (Studies have shown that many women stop taking their AIs because of the side effects.) This study is done by mail, phone and/or internet, and no visits are required.
This is a Phase II trial

  • Participation TimeNo visits required
  • No Visits Required for this TrialNo travel required 

Behavioral Weight Loss and Exercise After Treatment (BEAT) for Early-Stage Breast Cancer

Behavioral Weight Loss and Exercise After Treatment (BEAT): Predictors of Weight Loss Success in Overweight Breast Cancer Survivors (NCT02052115)

Summary

Studies have found that breast cancer survivors who are overweight and not physically active are at increased risk for a breast cancer recurrence. Side effects of cancer and its treatment, such as fatigue, distress and memory loss, may have an effect on a woman's ability to maintain a healthy diet, lose weight, or exercise. Researchers have developed a behavioral weight loss and exercise after treatment (BEAT) program for breast cancer survivors. This study is looking at the effectiveness of the BEAT program and whether side effects like fatigue, distress, and cognitive functioning impact the program's effectiveness.

HylaCare™ Cream to Reduce Side Effects from Radiation Therapy

Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast. (NCT02165605)

Summary

Radiation is commonly used after a lumpectomy to kill any cancer cells that may remain in the breast. Its side effects include skin changes such as redness, dryness, swelling, and peeling. HylaCare™ (hyaluronic acid-containing topical cream) is a cream that may be able to reduce these side effects. This study will compare the effectiveness of HylaCare™ to a placebo for treating skin changes caused by radiation therapy in women being treated for breast cancer. To be eligible, a woman must have plans to receive external beam radiation and not currently be using other skin care creams on her breast.

Cognitive-Behavioral Therapy for Insomnia After Treatment

Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment (NCT00672217)

Summary

Many cancer patients experience persistent difficulty falling asleep or staying asleep. Studies have shown that psychological and behavioral factors play an important role in insomnia. Cognitive behavioral therapy (CBT) is an effective treatment for insomnia that provides an alternative to sleeping pills. The CBT approach aims to change the thoughts and actions that interfere with the ability to get restful sleep. The goal of this study is to examine the effects of CBT on women who experience long-term difficulty with sleeping after cancer treatment. Participants must have completed radiation or chemotherapy within three years of beginning this study.

Healthy Living After Cancer: A Weight Management Pilot Study

Healthy Living After Cancer: Weight Management Pilot Study (NCT01978899)

Summary

Studies suggest that women and men who are overweight at the time of their cancer diagnosis are at increased risk of developing surgical complications, fatigue, a poor body image or other problems. Cancer patients who lose weight after their cancer diagnosis may experience fewer of these problems. Losing weight may also decrease a patient's risk of recurrence. Researchers want to determine which weight-loss program is best for cancer survivors. This study is evaluating the effectiveness of a 16-week diet and exercise program in women and men who have been diagnosed with cancer. (This study is enrolling patients with breast and other types of cancers.)

Providing Lymphedema Education to Breast Cancer Patients Prior to Surgery

Effect of Intensive Education on Breast Cancer Patient's Understanding of Lymphedema (NCT02073045)

Summary

Women and men who have breast cancer surgery are at risk of developing lymphedema—a painful swelling of the arm and hand. Educating patients about risk factors for and symptoms of lymphedema may improve their ability to identify, and reduce, these symptoms after surgery. This study is looking at the impact a lymphedema education program provided before surgery has on breast cancer patients. To be eligible, a patient must be scheduled for surgery at University Hospitals Seidman Cancer Center in Cleveland, Ohio.

Effect of Diet & Exercise Before Surgery In Overweight Postmenopausal Women with DCIS

Exploring Effects of Weight Loss on Ductal Carcinoma In Situ (NCT02224807)

Summary

Ductal carcinoma in situ (DCIS) is a stage 0, pre-cancer. Women with DCIS are at increased risk for developing breast cancer. Because it is not yet known which DCIS will progress on to breast cancer and which will not, currently most women are treated for DCIS with surgery and often radiation or hormone therapy. Post-menopausal women who are overweight are at increased risk for invasive breast cancer. Animal studies suggest that very low calorie diets may slow cancer growth. Calorie restriction in women with DCIS may reduce their risk of developing invasive breast cancer. This study is looking at the effect that diet and exercise have on biomarkers found in breast tissue and blood that provide information about cancer progression, hormonal status, inflammation, tumor proliferation and cell death. To be eligible, a woman must be overweight or obese (BMI: 25-39.9), postmenopausal and scheduled to have a lumpectomy or mastectomy for DCIS in three weeks or more.

Comparing Therapies for Depression Related to Breast Cancer

Interpersonal Therapy for Depression in Breast Cancer (NCT01191580)

Summary

Depression can negatively affect a cancer patient's adherence to treatment, survival, symptom management, psychosocial functioning, and quality of life. The goal of this trial is to compare the effectiveness of three different types of therapy (Interpersonal Psychotherapy, Problem-Solving Therapy, and Brief Supportive Psychotherapy) in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer who have been diagnosed with Major Depressive Disorder.
This is a Phase IV trial

Calcitriol to Prevent Hair Loss During Chemotherapy

A Phase I Dose-escalation Study, to Evaluate the Safety, Tolerability and Pharmacokinetics of a Topical Compound 31543 (Calcitriol, USP) in Adult Patients Receiving Chemotherapy for the Treatment of Breast Cancer (NCT01588522)

Summary

Researchers are trying to find ways to stop the hair loss that is associated with a certain type of chemotherapy. Paclitaxel (Taxol®) and docetaxel (Taxetere®) are taxane-based chemotherapies commonly used to breast cancer and are associated with hair loss. In this study, researchers want to determine the highest dose of a topical form (applied to the scalp) of vitamin D called calcitriol (compound 31543) that can be used by women who are being treated with a taxane-based chemotherapy for inoperable locally advanced or metastatic breast cancer. It is possible that topical calcitriol may prevent or reduce the hair loss associated with taxanes. To be eligible, participants must be scheduled to receive a taxane-based chemotherapy, and have a full head of hair prior to entering the study.
This is a Phase I trial

Exercise During Treatment for DCIS and Early-Stage Disease

Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory (NCT01157130)

Summary

Studies suggest that exercise may reduce the risk of a breast cancer recurrence as well as improve quality of life. Precisely how exercise reduces recurrence risk is not fully understood. However, scientists think that exercise during breast cancer treatment may affect proteins and hormones, such as insulin and estrogen, that are related to cancer growth. The goal of this trial is to determine the effect that exercise instruction has on exercise levels, biological measures, and psychosocial factors. To be eligible, participants must have been recently diagnosed with DCIS or early-stage breast cancer and not yet begun treatment. In addition, participants must be planning to receive treatment that includes chemotherapy and/or radiation.

Using MRI of the Heart to Study Effects of Radiation Therapy for Left-Sided Breast Cancer

Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy (NCT02199366)

Summary

Women who receive radiation therapy to treat breast cancer in their left breast are at risk of developing heart problems. Magnetic Resonance Imaging (MRI) scans produce detailed images of the inside of the body. This study is looking at whether MRI scans of the heart can identify changes in heart function that develop after radiation therapy. To be eligible, a patient must be scheduled to receive radiation therapy for a stage I-III left-sided breast cancer.
This is a Phase I trial

Nueva Vida Program for Latina Breast Cancer Survivors and Their Caregivers

Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers (NCT02222337)

Summary

Studies have found that Latina breast cancer survivors tend to have a lower quality of life than other breast cancer survivors. The problems Latina breast cancer survivors experience can affect their immediate family and friends. The goal of this study is to test and refine a skills building program called Nueva Vida that was created specifically for Latina survivors and their caregivers. To be eligible for this study, Latina breast cancer survivors and their caregivers must speak English or Spanish.

Text Messaging to Improve Adherence to Oral Chemotherapy Agents

Text Messaging to Improve Adherence to Oral Chemotherapy Agents (NCT01889511)

Summary

For chemotherapy drugs that come in pill form to be an effective cancer treatment, patients must take them on the schedule determined for them by their doctor. Studies suggest that patients miss their dose about one-third of the time. Receiving a text message may reduce the number of times a patient misses a chemotherapy dose. The goal of this study is to see if text messaging is a feasible and acceptable way to get patients to take oral chemotherapy treatments.

Early Identification and Treatment of Lymphedema

The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient (NCT01521000)

Summary

Lymphedema is a painful swelling of the arm that can develop as a result of breast cancer treatment. The goal of this study is to determine whether identifying lymphedema and treating it as early as possible can help keep it from progressing. The study is also investigating whether bioimpedance, a technique that uses electric current to measure tissue volume, is better than the methods that are currently available for measuring lymphedema.To be eligible, participants must have undergone a sentinel lymph node biopsy or axillary node dissection.

Ketogenic Diet in Advanced Cancer

A Low-Carbohydrate Diet for Advanced or Metastatic Cancer (NCT01716468)

Summary

Researchers are interested in whether a person's diet can affect tumor growth. In this study patients will be placed on a “ketogenic diet,” a high-fat, low-carbohydrate diet that has been used to treat difficult-to-control epilepsy in children. Studies have shown that tumors get energy from ketones converted from glucose, which is contained in carbohydrates. The researchers are testing whether, by reducing carbohydrates, this diet will cut off the tumor's main source of energy. The purpose of this study is to determine the safety and tolerability of a ketogenic diet in individuals with advanced breast cancer. The study will also look at whether the diet improves quality of life; effects tumor growth (size or spread); or has an effect on progression free survival (PFS) or overall survival (OS). To be eligible, participants must have tumors that have not responded to treatment or be on a treatment holiday.

Counseling for Breast Cancer Patients Age 70 and Over

Pilot of a Geriatric Group Psychoeducational Intervention for Elderly Patients With Cancer (NCT00984321)

Summary

Many women seek counseling after a breast cancer diagnosis. This counseling program was developed to meet the specific needs of older cancer patients, who often find themselves facing problems related to both cancer and aging. The goal of this trial is to see whether a counseling program can help reduce depression, anxiety, and feelings of loneliness and isolation as well as improve the quality of life of older women with breast cancer. To be eligible, participants must be receiving treatment at Memorial Sloan-Kettering Cancer Center.

Yoga for Breast Cancer Patients Undergoing Chemotherapy

A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms (NCT02360904)

Summary

Yoga is a mind-body intervention that has been shown to reduce fatigue and improve overall quality of life in breast cancer patients receiving chemotherapy. This study is comparing the effect that yoga has on quality of life when the classes are started immediately or three months after beginning chemotherapy. To be eligible, patients must be scheduled to receive chemotherapy or have been on chemotherapy for less than two weeks; not planning on starting yoga; and not have done yoga regularly within 3 months of enrolling in the study.

Acupuncture For Treating Post-mastectomy Pain, Nausea and Anxiety

A Pilot Randomized Controlled Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope. (NCT02122796)

Summary

Some of the most common side effects that occur after a mastectomy are pain, nausea, and anxiety. Acupuncture involves inserting thin, sterile needles at certain points in the body. Studies have found that acupuncture can help relieve fatigue, hot flashes, nausea, vomiting, and pain. This study is looking at whether acupuncture is better than the standard of care for reducing pain, nausea and anxiety after a mastectomy. To be eligible, patients must be scheduled to have a mastectomy to treat stage I-III breast cancer.

Brain (Cognitive) Problems in Breast Cancer Survivors

Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients (NCT01949376)

Summary

Between 30 and 70 percent of women who receive chemotherapy or hormone therapy after surgery experience changes in their memory or thought processes (cognitive functioning), some of which may be temporary. This study is investigating how these treatments change the size, shape and activity of different areas of the brain, and if these changes are linked to the development of mild brain (cognitive) problems. To be eligible for this study, a woman must have had surgery and be planning to have hormonal therapy (with or without chemotherapy) or no additional therapy. This study is also recruiting healthy women who have not been diagnosed with breast cancer.

Yoga During Radiation Therapy

Biobehavioral Effects of Yoga for Women With Breast Cancer Undergoing Radiotherapy (NCT01202851)

Summary

Researchers believe that mind-body interventions can be beneficial to women undergoing breast cancer treatment. Yoga is a mind-body intervention that has been shown to reduce fatigue as well as improve quality of sleep, physical vitality, and overall quality of life in women being treated for breast cancer. This study will compare the effectiveness of a yoga program with a stretching/relaxation program for improving the physical and emotional well-being of women with DCIS or Stage I-III breast cancer who are undergoing radiation treatment after surgery. The study will also include a group of women who will not take part in either the yoga or stretching/relaxation program. To be eligible, participants must be planning to receive radiation therapy following breast surgery. In addition, participants must not have practiced yoga in the year prior to breast cancer diagnosis.
This is a Phase III trial

A Nutritional Supplement to Improve Cognitive Function in Breast Cancer Survivors

Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors (NCT01823991)

Summary

COGNUTRIN is a nutritional supplement that includes fatty acids (Lovaza®) and blueberry extracts (Vitablue). Researchers believe this supplement may help improve memory and cognitive functioning in breast cancer survivors who have been treated with chemotherapy. This study will compare COGNUTRIN to a placebo in breast cancer survivors who were treated within the last three months with a chemotherapy regimen that included an anthracycline and a taxane.

Survivorship Care Planning to Improve Quality of Life

Survivorship Care Planning for At Risk Breast Cancer Survivors: A Focus on Latina-, Asian-, African-, and European Americans (NCT01824745)

Summary

Survivorship care planning may reduce stress and improve the well-being and quality of life of breast cancer survivors. The best method for providing survivorship care planning services is not yet known. This study is comparing the effectiveness of providing breast cancer survivors with a Survivorship Care Planning booklet along with four 40-minute counseling sessions to providing breast cancer survivors with a Survivorship Care Planning booklet alone. Women must live in Southern California and be 6-18 months post diagnosis--and at or nearing the end of their cancer treatment--to be eligible for this study.

Mouth Rinse to Prevent Mouth Sores in Women Taking Afinitor and an Aromatase Inhibitor

Evaluation of Miracle Mouthwash (MMW) Plus Hydrocortisone and Prednisolone Mouth Rinse as Prophylaxis for Everolimus-Associated Stomatitis (NCT02229136)

Summary

Studies show that mouth sores (stomatitis) are a common side effect in women taking the mTOR inhibitor everolimus (Afinitor®). Steroidal mouth washes may be able to keep these painful mouth sores from developing. Miracle Mouth Wash (MMW) and prednisolone are different types of steroid-based mouth washes. This study is looking at whether using MMW with hydrocortisone is more effective than using a prednisolone oral rinse for preventing or reducing mouth sores. To be eligible for this study, a woman must be postmenopausal and currently being treated with an aromatase inhibitor (letrozole (Femara®), exemestane (Aromasin®) or anastrozole (Arimidex®)) and Afinitor.
This is a Phase II trial

Massage to Reduce Anxiety Before Breast Cancer Surgery

Utility of Preoperative Massage in Breast Surgery Patients (NCT01667328)

Summary

It is not uncommon for patients to report feeling anxious prior to their breast cancer surgery. Studies have demonstrated that massage can offer some health benefits for people with cancer. Massage has also been found to be help reduce anxiety. This study is investigating whether breast cancer patients who receive massage therapy by a licensed massage therapist before surgery have lower anxiety levels than those who do not receive massage therapy.

Comparing Two Types of Support Groups for Women with Metastatic Breast Cancer

Self-management Interventions for Pain in Advanced Breast Cancer (NCT01927081)

Summary

Studies have found that breast cancer patients often benefit from talking about their illness with other breast cancer patients. Support groups can foster these types of discussions. This study is comparing two different types of support groups for women with metastatic breast cancer. To be eligible, a woman must be receiving breast cancer care at the Duke Cancer Institute in Durham, North Carolina.

Acupressure for Persistent Cancer Related Fatigue

Acupressure for Persistent Cancer Related Fatigue (NCT01281904)

Summary

Persistent Cancer-Related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms breast cancer survivors may experience. There currently are few treatment options for PCRF. Acupressure is a technique derived from acupuncture, a component of Traditional Chinese Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand or elbow or with a special device. Pilot studies suggest that self-administered acupressure may be a promising treatment for PCRF. The goal of this study is to determine the benefit of acupressure for treating PCRF in breast cancer survivors who have completed cancer treatments. (Individuals on anti-estrogen therapy, such as tamoxifen or an aromatase inhibitor, can also participate.) To be eligible, participants must have a complaint of persistent, moderate to severe fatigue despite standard treatment.
This is a Phase II-III trial

Swedish Massage Therapy to Reduce Cancer-Related Fatigue in Breast Cancer Survivors

Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer (NCT01926678)

Summary

Many cancer survivors experience cancer-related fatigue. Studies suggest that individuals whose immune system is continually activated may experience more fatigue. Decreasing this immune system activation may help to reduce symptoms of cancer-related fatigue. Swedish Massage Therapy is a type of massage that may help reduce immune system activation. This study is comparing the effect that Swedish Massage Therapy, light touch therapy, and and being put on a wait list for massage therapy have on the immune system of breast cancer survivors who are experiencing cancer-related fatigue.
This is a Phase II trial

Yoga for Breast (and Ovarian) Cancer Survivors

Yoga Practice for Breast or Ovarian Cancer Patients: A Pilot Study (NCT02305498)

Summary

Studies have found that physical activity can reduce the risk of a breast cancer recurrence. Laboratory studies suggest that stress may help cancer cells grow. Yoga is a mind-body practice that combines physical activity and stress-reduction. It can help reduce fatigue as well as improve quality of sleep, mood, memory, concentration, physical fitness, and overall quality of life. Researchers would like to conduct a large study of a yoga program for breast cancer survivors.This study is comparing two different types of yoga programs for breast cancer survivors. Information from this study will be used to design the larger yoga study. To be eligible, a woman may not have had a mastectomy. This study also is open to ovarian cancer survivors.

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. (NCT01521741)

Summary

Breast cancer treatments can result in long-term, painful swelling of the arm and hand, a condition called lymphedema. The goal of this study is to determine how the symptoms and functional disability that accompany lymphedema can impact breast cancer survivors' quality of life. To be eligible, participants must be planning to have surgery and receive follow-up care for breast cancer at Massachusetts General Hospital.

Enalapril to Protect the Heart from Side Effects of Doxorubicin

The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment (NCT00895414)

Summary

Doxorubicin (Adriamycin®) is a standard breast cancer chemotherapy treatment. It is effective, but it can also cause heart damage. Enalapril maleate (Vasotec®) may help protect heart cells from the side effects of doxorubicin. It is not yet known whether it is more effective to give enalapril maleate before or after the doxorubicin. The main purpose of this study is to investigate whether there is a drug interaction that occurs between enalapril and doxorubicin and whether enalapril has any effect on how doxorubicin is metabolized. To be eligible, participants must be planning on receiving treatment with doxorubicin.

L-Glutamine to Reduce Numbness and Tingling in Patients with Chemo-Induced Neuropathy

L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer (NCT02215083)

Summary

Peripheral neuropathy--numbness and tingling in fingers or toes--is a common side effect of certain types of chemotherapy. L-glutamine is an amino acid that plays a role in the health of the immune system. Previous studies have found that L-glutamine can help keep peripheral neuropathy from developing in breast cancer patients who take it while they are receiving a taxane chemotherapy, such as Abraxane®, Taxol®, or Taxotere®. This study is looking at whether L-glutamine can reduce numbness and tingling in breast cancer patients who have already developed taxane-induced peripheral neuropathy. To be eligible, participants must have received at least one prior taxane-containing chemotherapy.
This is a Phase I trial

Tibetan Meditation & Quality of Life in Women Who Had Chemo and are on Hormone Therapy

Effects of Meditation on Cognitive Function and Quality of Life (NCT02162329)

Summary

Tibetan Bon meditation uses breathing to calm the mind and body. It also uses sounds to help connect the mind and body during the meditation practice. Researchers think Tibetan Bon meditation may help alleviate side effects of cancer and its treatments. This study is looking at the effect that Tibetan Bon meditation has on brain functioning and quality of life in women who have been treated for stage I - III breast cancer with neoadjuvant (before surgery) or adjuvant (after surgery) chemotherapy and are currently taking tamoxifen or an aromatase inhibitor.

Mouthwash to Prevent Mouth Sores in Postmenopausal Women Starting Afinitor and Aromasin

A Phase II, Single Arm Study of the Use of Steroid-based Mouthwash to Prevent Stomatitis in Postmenopausal Women With Advanced or Metastatic Hormone Receptor Positive Breast Cancer Being Treated With Everolimus Plus Exemestane (NCT02069093)

Summary

Everolimus (Afinitor®) is used along with exemestane (Aromasin®) to treat postmenopausal women with advanced ER+ breast cancer. Mouth sores (stomatitis) are a common side effect of Afinitor and if the mouth sores get too bad a woman may need to stop treatment. Dexamethasone is a medication that is used to relieve inflammation (swelling, heat, redness, and pain). Researchers think that a mouthwash made from dexamethasone may help prevent or reduce mouth sores. This study is looking at whether a dexamethasone mouthwash can help prevent mouth sores in postmenopausal women with advanced hormone-sensitive, HER2-negative breast cancer. To be eligible, participants must start their treatment with Afinitor and Aromasin at the same time they start the mouthwash study.
This is a Phase II trial

Topical Menthol Cream for Chemotherapy-Induced Neuropathy

Topical Menthol for CIPN: a Randomized, Placebo Controlled Phase II Trial (NCT01855607)

Summary

Peripheral neuropathy—nerve damage that causes pain or discomfort in the hands and feet—is a potential side effect of the taxane drugs used in many chemotherapy regimens. Menthol is often used in pain relieving balms, massage oils and liniments because it is cooling and anaesthetic when applied to the skin. This study is investigating whether a topical cream that contains menthol is more effective than a topical cream that does not contain menthol in reducing neuropathy-related pain in breast cancer patients. To be eligible, participants have completed Taxane-based breast cancer therapy within the last two years and have experienced neuropathy in the hands and feet frequently in the past seven days.
This is a Phase II trial

Diet and Exercise Program for Overweight Survivors

Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention. (NCT01630499)

Summary

Breast cancer survivors who are overweight or obese are at greater risk for having a breast cancer recurrence as well as for other health problems, like heart disease. The purpose of this study is to compare a tailored nutrition, physical activity, and behavioral weight management program for breast cancer survivors against a widely available commercial weight management program. The researchers are interested in learning whether an intervention tailored to the unique psychological, nutritional and physical needs of breast cancer survivors will provide superior physiological and psychological benefits than the existing commercial program. To be eligible, participants must have a BMI of 27 to 45.

Increasing Physical Activity During Chemotherapy for Early Stage Breast Cancer

A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer (NCT02159157)

Summary

Researchers have found that breast cancer survivors who are physically active are at lower risk of having a breast cancer recurrence. Recent studies suggest that taking part in physical activities during cancer treatment may also be beneficial. There are different ways to encourage breast cancer patients to become more active during their treatment. This study is comparing two approaches to increasing physical activity in breast cancer patients who are scheduled to begin chemotherapy. To be eligible, participants must be scheduled to begin treatment within 4 weeks.

Aerobic Exercise for Women with Metastatic Breast Cancer

Phase II Trial of Aerobic Training in Metastatic Breast Cancer (NCT01725633)

Summary

Breast cancer treatments can have an affect on quality of life and fitness. Aerobic exercise may help to improve quality of life and fitness. The purpose of this study is to determine the safety and feasibility of a supervised aerobic training program for women with metastatic breast cancer who are being treated with hormone therapy, chemotherapy, and/or radiation. To be eligible, participants must be receiving breast cancer treatment at Duke University Medical Center (DUMC), Durham Regional Hospital, or Duke Raleigh.
This is a Phase I trial

Massage to Reduce Pain and Increase Mobility After Breast Surgery

Massage for Pain and Mobility in Post-Breast Surgery Patients (NCT02250898)

Summary

Breast surgery can result in chronic pain and a lack of mobility in the chest and/or shoulder. Pain medication and/or physical therapy are often used to try to reduce this pain, but new methods are needed. Myofascial massage is a massage technique used to try to break up scar tissue. This type of massage may help reduce pain, inflammation and tissue sensitivity and increase mobility. This study is looking at whether myofascial massage to the breast, chest and shoulder area is more effective than a general relaxation body massage for reducing pain and increasing mobility in women who have had breast surgery. To be eligible, a woman must have had breast surgery within the previous 2-18 months.

Studying Cognitive Changes Before and After Radiation Therapy for Brain Metastases

A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases (NCT01445483)

Summary

Radiotherapy is the most frequently used therapy for breast cancer brain metastases. However, cognitive dysfunction may be a side effect of this treatment. Currently there are no standardized tests to measure changes in cognitive functioning in patients treated for brain metastasis. In this trial, researchers will test a patient's memory, attention, processing speed, and reading and fine motor skills before and after radiation therapy to the brain to find out if this treatment causes a change in patients' cognitive and daily functioning.

Estrogen Levels in Women Given Vaginal Estrogen to Reduce AI-Related Vaginal Dryness

A Single-arm Phase II Trial to Evaluate Serum Estradiol Levels in Patients With Breast Cancer Treated With Vaginal Estrogen, Estring (NCT01923298)

Summary

Hormone-sensitive (ER+ and/or PR+) breast cancer is the most common type of breast cancer. In postmenopausal women, these tumors are typically treated with an aromatase inhibitor—anastrazole (Arimidex®), letrozole (Femara®) or exemestane (Aromasin®). One of the most common side effects associated with these therapies is vaginal pain and dryness. Estring® is a vaginal ring that delivers estrogen to the inside of the vagina. It is not known if this type of local estrogen therapy increases estrogen levels in the blood, which might, in turn, increase the risk of a breast cancer recurrence. This study is monitoring blood estrogen levels in postmenopausal women who are on an aromatase inhibitor (AI) and using the Estring. To be eligible, a woman must be taking an AI, have had vaginal pain and dryness for at least two weeks, and have tried at least one other vaginal dryness treatment.
This is a Phase II trial

Acupuncture To Treat Chemotherapy-Induced Neuropathy

Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (NCT01881932)

Summary

Peripheral neuropathy is a common side effect of chemotherapy. It usually includes pain, tingling, and numbness in the fingers and toes. This may cause a patient to receive a lower dose or a change of medication. Acupuncture, a technique used in traditional Chinese medicine, is commonly used to treat pain. Previous studies suggest that acupuncture could be effective in controlling neuropathy. This study will determine the effectiveness of using acupuncture to manage the pain, tingling and numbness caused by chemotherapy and if this treatment can help prevent reducing the dose of chemotherapy. To be eligible, participants must be receiving chemotherapy that includes a taxane or oxaliplatin and be experiencing symptoms of neuropathy.

Detecting and Monitoring Lymphedema

Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report (NCT01544335)

Summary

Lymphedema is a painful swelling of the arm that can develop as a result of breast cancer treatment. Early detection and treatment of lymphedema may be able to help reduce or control this swelling. To improve early detection, better methods of measuring lymph fluid in the arm are needed. Bioimpedance spectroscopy involves using an extremely small electrical current to measure the amount of lymph fluid present in the arm. The goal of this study is to determine whether bioimpedance spectroscopy is as effective at detecting and monitoring lymphedema as a measurement device called a perometer. To be eligible, participants must be receiving follow-up care at Massachusetts General Hospital or the Dana-Farber/Harvard Cancer Center.

Web-Based Support for Patients Managing Lymphedema

Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors (NCT01779063)

Summary

Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors. As a progressive condition, breast cancer treatments can cause lymphedema, a painful swelling of the arm and hand. Lymphedema is a lifelong condition that requires daily self-care, which can be physically and emotionally challenging. Researchers are trying to develop new ways to help breast cancer patients manage their lymphedema. One new program that may be effective includes a Web-based, multimedia intervention and a "take home" manual that supports self-care. This study is comparing this new Web-based program to an educational booklet now in use to see which does a better job of improving breast cancer survivor's self-care behaviors, addressing their physical and emotional concerns and reducing the money they spend on lymphedema treatment.

Spousal Relationships and Pain in Metastatic Breast Cancer

Spousal Relationships and Pain in Metastatic Breast Cancer (NCT00386620)

Summary

Researchers are interested in learning more about the needs and preferences of metastatic breast cancer patients and their partners. The goal of this psychosocial research study is to look at factors that may affect the pain experience of patients with metastatic breast cancer. The study is also investigating whether women with metastatic breast cancer and their spouses can use a hand-held computer program designed to assess patient pain, spouse response to patient pain, and patient behavior in response to pain. Women experiencing pain related to their metastatic breast cancer diagnosis are eligible. The woman's male spouse or significant other will be asked to participate.

Scalp Cooling to Prevent Hair Loss Caused By Chemotherapy For Stage I-II Breast Cancer

Scalp Cooling for Alopecia Prevention (SCALP) (NCT01986140)

Summary

Hair loss is a common side effect of many chemotherapy drugs. Studies suggest that cooling the scalp during chemotherapy treatment may reduce hair loss. The Paxman Orbis Hair Loss Prevention System uses a soft lightweight silicone cap, which is placed on the patient’s head. The cap is connected to a small compact refrigeration system that applies cold temperature to the scalp during chemotherapy. The cold temperature numbs the scalp, which reduces blood flow and prevents chemotherapy drugs from reaching hair follicles. This study is evaluating the effectiveness and tolerability of using the Paxman Orbis Scalp Cooler to prevent hair loss during chemotherapy. To be eligible, participants must be planning to undergo treatment with anthracycline- or a taxane-based chemotherapy.
This is a Phase III trial

Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

A Randomized Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients (NCT02129686)

Summary

Peripheral neuropathy—nerve damage in the hands and feet—is a common side effect of chemotherapy. People with peripheral neuropathy experience pain, tingling, burning, or a numbness sensation, which can lead to balance or movement problems. Acupuncture involves inserting hair-thin, stainless steel needles into specific points on the skin. Studies have found that acupuncture can reduce some types of pain. Researchers are interested in seeing if acupuncture can reduce pain in the hands and feet caused by chemotherapy-induced peripheral neuropathy. This study will evaluate the effectiveness of using acupuncture to treat breast cancer patients who completed chemotherapy and are experiencing symptoms of peripheral neuropathy.

Treating Skin Irritation Caused by Radiation Treatment for Breast Cancer

Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation:A Randomized Trial, Double Blind Trial (NCT01856543)

Summary

Skin irritation is a common side effect of radiation therapy. Eucerin is an over-the-counter lotion that often is recommended during breast cancer radiation to prevent the treated skin from becoming dry or peeling. Mometasone furoate is a cream that is used to treat skin redness and irritation. This study is comparing the effectiveness Eucerin and mometasone furoate to treat skin irritation in women receiving radiation after a mastectomy. To be eligible, participants must have had a mastectomy for breast cancer and be planning to receive post-mastectomy radiation.
This is a Phase III trial

BEAT Exercise Program for Early-Stage Survivors

Enhancing Physical Activity Adherence After Breast Cancer Diagnosis: Randomized Trial (NCT00929617)

Summary

Studies suggest that physical activity may reduce a woman's risk of a breast cancer recurrence as well as improve quality of life. Exercise can also help with weight management and the control other health conditions. However, it is not uncommon for breast cancer survivors to become less active during their treatment and/or to not return to the level of activity they had prior to their diagnosis. The "BEAT" exercise program is designed to encourage breast cancer survivors to increase their physical activity. The goal of this study is to determine if women who take part in the "BEAT" exercise program become more physically active and have better health outcomes than women not in the program. To be eligible, participants must have completed treatment (except hormone therapy, if applicable) and must currently not do more than 20 minutes of physical activity two days per week.

Glutamine for Chemotherapy-Related Neuropathy

A Randomized Placebo-Controlled Trial of Glutamine to Reduce the Signs and Symptoms of Peripheral Neuropathy in Breast Cancer Patients With a Mild Peripheral Neuropathy Receiving Paclitaxel Chemotherapy (NCT00195013)

Summary

Peripheral neuropathy is a common side effect of chemotherapy. It usually includes numbness, tingling, or painful feelings in the fingers and toes. Previous research has shown that the amino acid glutamine may help to prevent or reduce the development of these symptoms. The goal of this study is to further investigate the effect of glutamine on peripheral neuropathy and to figure out why people experience peripheral neuropathy after receiving chemotherapy. Participants must be receiving or have recently completed paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®) chemotherapy.
This is a Phase III trial

A Program to Help Metastatic Breast Cancer Patients Participate in Treatment Decisions

Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer (NCT01811264)

Summary

Women who are actively involved in their health care tend to feel better about the treatment they are receiving. Researchers have developed a brief Patient Participation Aid that uses text and images to teach patients how to ask questions and assert personal preferences. This study is investigating whether the Aid improves the well-being of women with metastatic breast cancer by empowering them to be active participants during doctor's appointments. To be eligible, participants must have metastatic breast cancer and be receiving care at one of the participating study clinics.

MDMA-Assisted Therapy for Anxiety Related to Metastatic Cancer

Phase II Dose-Response Pilot Study of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Anxiety Associated With Advanced-Stage Cancer (NCT00252174)

Summary

A diagnosis of advanced stage cancer can cause intense anxiety. MDMA (3,4-methylenedioxymethamphetamine) may be able to help relieve this anxiety by producing feelings of closeness to others, empathy, wellbeing, and insightfulness. MDMA has been previously shown by some psychotherapists to reduce anxiety and improve quality of life in terminally ill patients. Currently, it cannot be used outside of research studies. This study will examine the effects of MDMA-assisted psychotherapy in patients who have received a diagnosis of advanced stage cancer. Participants must have completed or decided to end all cancer treatments prior to beginning this study.
This is a Phase II trial

Health Education for Reducing Chemotherapy-Related Weight Gain

Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy (NCT01941784)

Summary

Weight gain is a common side effect of chemotherapy treatment. The average patient gains about 5-8 pounds over a year. THRIVE (Taking Health Realization Into Valued Eating and Exercise) is a health education program that may help reduce weight gain and improve the quality of life of women undergoing chemotherapy. The goal of this study is to determine the effectiveness of the THRIVE project for preventing weight gain associated with chemotherapy treatments in women with newly diagnosed stage I-IV breast cancer who have recently started or are schedule to receive chemotherapy.

In-Home Foot Reflexology for Breast Cancer Patients

Home-Based Symptom Management Via Reflexology for Breast Cancer Patients (NCT01582971)

Summary

Reflexology is a complementary medicine technique that involves applying firm pressure to certain parts of the sole of the foot. Its practitioners believe that there are areas on the foot that correspond to areas of the body, and that manipulating these areas can improve health. The purpose of this project is to see if weekly foot reflexology that is delivered by a friend or family member improves the quality of life of women who are receiving chemotherapy or hormone therapy as part of their breast cancer treatment.

Using MRI and PET to Learn More About Chemobrain after Breast Cancer

A Multi-modality Imaging Assessment of Chemobrain (NCT00708045)

Summary

Cognitive dysfunction, better known as "chemobrain" is a well-known side effect of cancer and its treatments. Its symptoms can include an inability to concentrate, memory dysfunction, word finding difficulties, and the inability to multitask. FDG-PET (Radiopharmaceutical fluorodeoxyglucose-Positron Emission Tomography) is an imaging technique that allows doctors to see how the brain activates. Functional MRI (fMRI) allows doctors to see how the brain works when you are trying to concentrate or remember something. In this study, these imaging techniques will be used to learn more about chemobrain. To be eligible, participants must have had their breast cancer treated at the Huntsman Cancer Institute in Salt Lake City, Utah.

Studying the Effect of Chemotherapy on the Brain in Older Women

A Pilot Study of Structural and Functional Brain Magnetic Resonance Imaging Findings of Chemotherapy Toxicity in Older Women With Breast Cancer (NCT01992432)

Summary

Chemotherapy can cause short-and long-term difficulties with cognitive functioning, a problem often referred to as "chemo brain." Older adults may be at increased risk of developing cognitive problems from chemotherapy. This study will use advanced MRI techniques to characterize the changes that occur in the brain of women age 65 and older receiving adjuvant chemotherapy. Results of this study will lay the foundation for future, larger scale studies on the impact of chemotherapy on cognitive functioning in adults age 65 and older.

Reducing Post-Operative Pain From Breast Reconstruction

A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction (NCT02044302)

Summary

Opioids and sedatives like diazepam (valium) are the drugs typically used to manage pain in women who are having a mastectomy with breast reconstruction. Opioids are effective, but they can cause side effects like nausea, vomiting, sedation, and constipation. Bupivacaine is a local anesthetic. Botulinum toxin (commonly known as Botox) is a muscle relaxant. Both block the nerve impulses that send pain signals to the brain. This study is investigating whether using bupivacaine and Botox, either alone or together, during surgery will provide better pain control post-surgery and reduce incidences of opioid side effects in women who are having a mastectomy with breast reconstruction.
This is a Phase II trial

Multi-Media Support Program for Post-Treatment Survivors

Multi-Media Imagery Program for Breast Cancer Patients (Phase II) (NCT01034215)

Summary

Many women who have been treated for early stage breast cancer experience long-term effects, such as chemobrain, fatigue, sleep deprivation, stress, anxiety, depression, and post-traumatic stress disorder (PTSD). The goal of this study is to evaluate the effectiveness of a multi-media program, called "Envision the Rhythms of Life," that aims to reduce stress and improve quality of life. The program uses animation, PowerPoint, manuals, art, and audio-art. To be eligible, it must be at least six weeks since the completion of surgery, radiation, and/or IV-delivered chemotherapy.
This is a Phase II trial

Anti-Inflammatory Drug to Reduce Breast Density and Breast Pain

NSAID Effects on Clinical and Imaging Breast Biomarkers (NCT01761877)

Summary

Sulindac (Clinoril®) is prescription drug that is used to treat inflammation and arthritis. Researchers are interested in seeing if it might help reduce breast cancer risk by decreasing breast density. They are also interested in seeing if it can reduce the pain and stiffness caused by the aromatase inhibitors used to treat breast cancer. This study will allow the researchers to gain information that can help answer both of those questions. It will enroll women who have completed primary treatment for early-stage breast cancer who have been taking the aromatase inhibitor anastrazole (Arimidex®) for at least three months.
This is a Phase II trial

Improving Fertility Preservation

A Randomized Open Label Clinical Trial of Fixed Dose Letrozole vs. Titrated Letrozole for In Vitro Fertilization With Cryopreservation of Oocytes and Embryos in Breast Cancer Patients (NCT01035099)

Summary

Some breast cancer treatments may affect a woman's ability to become pregnant. Women can choose to undergo in vitro fertilization (IVF) prior to chemotherapy or radiation so that they can store their eggs and try to become pregnant at a later date. IVF involves ovarian stimulation and egg retrieval. Conventional ovarian stimulation often results in very high estrogen levels, which may be unsafe for breast cancer patients. Letrozole (Femara®) is an aromatase inhibitor used to treat hormone-sensitive tumors in postmenopausal women. It can reduce estrogen levels during IVF while still allowing for effective ovarian stimulation. This trial will compare the effectiveness of two different ways of administering letrozole during ovarian stimulation in patients who are scheduled to undergo IVF for fertility preservation due to breast cancer.

Exercise & Weight Loss for Overweight Survivors With Lymphedema

The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies (NCT01515124)

Summary

Lymphedema is a painful swelling of the arm or hand that can be caused by breast cancer treatments. Women who are overweight are more likely to develop severe lymphedema. This is a one-year study that will look at whether weight loss and/or exercise can help reduce lymphedema symptoms in inactive breast cancer survivors who are overweight or obese and who have already developed breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The researchers will also investigate whether exercise and/or weight-loss reduces the risk of recurrence and improves quality of life. To be eligible, participants must have a BMI of 25 or greater.
This is a Phase III trial

Light Exposure to Reduce Fatigue Related to Cancer & Cancer Treatments

Treating Cancer-Related Fatigue Through Systematic Light Exposure (NCT01873794)

Summary

Cancer and its treatments can can cause a persistent state of exhaustion that is often referred to as cancer related fatigue (CRF). In some patients, this exhaustion can severely interfere with activities of daily living even years after treatment has ended. There is currently no effective treatment for CRF. Researchers believe that systematic light exposure (SLE)—a daily 30-minute exposure to light from a commercially available light box—may improve sleep and quality of life and decrease fatigue and depression in cancer survivors. To be eligible, breast cancer patients must have had chemotherapy as part of their cancer treatment, have completed treatment up to 3.5 year ago, and be experiencing fatigue or cognitive problems.

Electroacupuncture to Reduce Nerve Pain Caused by Taxol®

Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy (NCT01163682)

Summary

The chemotherapy drug paclitaxel (Taxol®) is a widely used effective breast cancer treatment. However, one of its common side effects is nerve and muscle pain. Acupuncture is a technique used in traditional Chinese medicine that involves the insertion of hair-thin needles into various points in the skin. Electroacupuncture is a form of acupuncture in which pairs of acupuncture needles are attached to a device that generates electrical pulses between them. Studies have shown that it can help to relieve pain. This trial is investigating whether giving electroacupuncture during paclitaxel treatment can help to prevent or decrease nerve pain. To be eligible, participants must be planning to receive weekly paclitaxel for 12 weeks after surgery for early-stage breast cancer and must never have received acupuncture treatment.
This is a Phase I trial

Lymphedema Prevention and Detection

To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-Risk Status (NCT00383500)

Summary

The purpose of this research study is to detect patients who might be at increased risk for the development of arm lymphedema based upon repeated non-invasive examination of the arms. When preventive interventions are appropriate, this study will compare the effectiveness of the usual treatments of massage and elastic sleeves with a new device, Flexitouch, which electronically simulates the effect of massage upon lymph flow.

Evaluating A Weight-Loss Program for Overweight Breast Cancer Survivors

Lifestyle, Exercise and Nutrition (LEAN) Study 2 (NCT02110641)

Summary

Studies have found that women who are overweight when diagnosed with breast cancer are at increased risk of having a breast cancer recurrence. This is believed to be, in part, because fat tissue raises estrogen levels. In addition, women who are overweight often have high insulin levels—which studies suggest increases cancer risk. Researchers are trying to determine which diet and exercise programs can help overweight breast cancer survivors lose weight. This study is evaluating the efficacy and cost-effectiveness of a 6-month weight-loss program. To be eligible, participants must have completed primary treatment for breast cancer at least two months prior to starting the study and have a BMI (body mass index) > 25.
This is a Phase III trial

Effects of an Electro-kinetic Beverage on Chemo-Related Insomnia, Fatigue & Depression

A Pilot Study Evaluating the Effect of 'R' (Electro-Kinetically Altered Beverage) on Insomnia, Fatigue and Depression in Breast Cancer Patients Receiving Adjuvant Chemotherapy (NCT02217033)

Summary

Breast cancer patients being treated with chemotherapy are at risk of developing insomnia, fatigue, and/or depression. An electro-kinetic beverage (like a sports beverage) is water with added minerals, such as calcium chloride, magnesium chloride and potassium bicarbonate. Researchers think an electro-kinetic beverage may reduce insomnia, fatigue and depression that develop during chemotherapy. This study will compare the effectiveness of an electro-kinetic beverage and a placebo for reducing levels of insomnia, fatigue, and/or depression in breast cancer patients receiving chemotherapy. To be eligible, participants must be planning to be treated with chemotherapy treatment of TC (docetaxel and cyclophosphamide).

Effect of NAC on Fatigue and Cancer Cells in Women with DCIS or Stage I Breast Cancer

Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer (NCT01878695)

Summary

N-acetylcysteine (NAC) comes from L-cysteine, a naturally occurring amino acid. Oral forms of NAC can be purchased over-the-counter. An injectable (IV) form of NAC is used to protect the liver in cases of acetaminophen (Tylenol®) overdose. Studies suggest that NAC can reduce fatigue. Researchers are interested in seeing if it can reduce fatigue in women being treated for breast cancer. They are also interested in learning if NAC might have an effect on cancer cells. This study is looking at the safety of giving combined oral and IV NAC to patients with DCIS and stage I breast cancer. The researchers will study the effect that NAC has on cancer fatigue and on breast cancer cells.
This is a Phase I trial

Cymbalta® for Breast Cancer Treatment-Related Chronic Pain

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients With Chronic Pain (NCT01912612)

Summary

Studies suggest that 25 to 60 percent of early-stage breast cancer survivors experience chronic pain as a result of their cancer treatments. Duloxetine (Cymbalta®) is approved by the U.S. Food and Drug Administration for the treatment of depression, anxiety, fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain. Pilot studies suggest that Cymbalta can reduce pain caused by cancer treatments. This trial will compare Cymbalta to a placebo by having every participant take each drug for seven weeks.To be eligible, a woman must have been diagnosed with stage 0-III breast cancer within the last eight years and be experiencing treatment-related pain that is between 4 and 10 on a 0-10 scale.
This is a Phase II trial

Lifestyle Changes During Radiation Therapy to Improve Outcomes

The Role of Lifestyle Factors in Breast Cancer-Related Outcomes (NCT02079662)

Summary

Researchers are studying the effects that lifestyle has on the risk of a breast cancer recurrence, quality of life, physical functioning, hormone levels and immune function. This study is looking at the effect that a comprehensive lifestyle change program that addresses diet, exercise, and stress has on women with stage III breast cancer who are scheduled to have a 4 to 6-week course of radiation. To be eligible patients must have a body mass index (BMI) of 25 or higher. They must also not eat more than 3 servings of fruits/vegetables a day or exercise more than 75 minutes per week.

Acupuncture for Joint Pain Caused by an Aromatase Inhibitor

Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women With Early Stage Breast Cancer (NCT01535066)

Summary

Aromatase inhibitors are used to treat hormone-sensitive tumors in postmenopausal women. One of the most common side effects associated with these drugs is joint pain and stiffness. A small study found that acupuncture can be an effective treatment in early stage breast cancer patients on an aromatase inhibitor experiencing joint pain and stiffness. This larger study is being conducted to confirm those results. It is comparing the effects of acupuncture, sham acupuncture or being placed on a wait list on joint pain in women with early-stage breast cancer taking an aromatase inhibitor. Patients not assigned to the acupuncture group will receive acupuncture at the end of the study.
This is a Phase III trial

A Computer-Based Intervention to Help Manage Fear of Recurrence

Attention and Interpretation Modification (AIM) for Fear of Breast Cancer Recurrence: An Intervention Development Study (NCT01517945)

Summary

It is not uncommon for women and men who have been treated for breast cancer to have a difficult time getting past the fear that they will have a cancer recurrence. The goal of this study is to develop and test a computer-based intervention program that was specifically developed to help early-stage breast cancer survivors cope with the fear of recurrence. To be eligible, participants must have finished cancer treatment (current hormone therapy is allowed) more than 1 year but less than 5 years ago.

LIVESTRONG Exercise Program For Cancer Survivors

Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors (NCT02112149)

Summary

Studies suggest that exercise can reduce the risk of a breast cancer recurrence. LIVESTRONG at the YMCA is a 12-week, small group exercise program developed for adult cancer survivors. The program is designed to help build muscle mass and muscle strength, increase flexibility and endurance, and improve functional ability. It may also reduce treatment side effects, prevent weight gain, and improve energy levels and self esteem. This study is evaluating the effect of the LIVESTRONG exercise program in 200 cancer survivors. This study is enrolling survivors of breast and other types of cancer.
This is a Phase III trial

Helping Patients Learn to Cope with Symptoms and Side Effects of Cancer and its Treatments

Patient Outcomes of a Self-care Management Approach to Cancer Symptoms: A Clinical Trial (NCT02288169)

Summary

Cancer and its treatments can result in symptoms and side effects that lead to depression, anxiety and a diminished quality of life. Helping patients learn how to manage difficult symptoms on their own may diminish suffering, improve quality of life and decrease emergency room visits and associated costs. COPE (Creativity, Optimism, Planning, Expert guidance) is a program initially developed by researchers at the University of South Florida to help cancer caregivers. This study is looking at whether the COPE program works well for cancer patients too. This study is enrolling patients with breast, colorectal, lung or prostate cancer patients who are experiencing distress.

Exercise for Early-Stage Survivors on Aromatase Inhibitors

Combined Exercise Program for Early Breast Cancer Survivors (NCT01140282)

Summary

Three aromatase inhibitors — letrozole (Femara®), anastrozole (Arimidex®), and exemestane (Aromasin®) — are widely used as adjuvant (after surgery) treatment in women with hormone-sensitive tumors. These drugs, however, frequently cause side effects that can affect quality of life, such as vaginal dryness, loss of libido, sleep problems, joint pain, fatigue, and bone loss. Researchers believe that regular physical activity may offset some of these side effects. Exercise also can improve bone health and help prevent osteoporosis. The goal of this trial is to assess the value of a community-based exercise program in early-stage breast cancer survivors who are currently taking an aromatase inhibitor. To be eligible, participants must not currently exercise more than 60 minutes per week.

A Program to Increase Cancer Screening, Reduce Depression in Women in the Bronx

Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women Project (NCT02273206)

Summary

Researchers are trying to increase cancer screening rates among low-income minority women in the Bronx County, New York. Women who are depressed may not get necessary cancer screening tests. Within New York City, the highest rates of depression are found in the Bronx. In this study, researchers are comparing two types of collaborative care programs that have been developed to reduce depression and improve cancer screening and cancer outcomes among low-income minority women from the Bronx. To be eligible, women must be between the ages of 50 and 64, a resident of the Bronx, screen positive for depression, overdue on breast cancer and other cancer screening tests, and not have been diagnosed with cancer within the past six months.

Nutrition Education and Acupuncture for Weight Loss After Chemotherapy

Comparison of Weight Loss Among Early Stage Breast Cancer Patients Post Chemotherapy: Nutrition Education in Combination With Weight Loss Acupuncture Vs. Nutrition Education Alone (NCT02081612)

Summary

Studies have found that women with breast cancer who are overweight or who gain weight after their diagnosis are at increased risk of having a cancer recurrence. Acupuncture uses hair-thin needles to stimulate energy in the body. Acupuncture may help improve short and long-term weight loss among breast cancer survivors who have been treated with chemotherapy. This study is investigating whether using acupuncture along with a nutrition education program is better than using a nutrition education program alone in helping breast cancer survivors lose weight. To be eligible, participants must have completed breast cancer treatment and have a body mass index (BMI) of 30 or greater.

Black Cohosh Before Surgery for Ductal Carcinoma in Situ

A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ (NCT01628536)

Summary

Black cohosh is an herb that is sold as a dietary supplement to treat hot flashes and other menopausal symptoms. Researchers are investigating whether it could also play a role in breast cancer treatment. This pilot study is investigating whether black cohosh can reduce the overall size and aggressiveness of DCIS when it is given prior to surgery.

Exercise or Mind-Body Program Before Surgery

The Preoperative Health & Body Study (NCT01516190)

Summary

This study is designed to look at the changes that occur in women who take part in exercise and mind-body programs between their breast cancer diagnosis and breast surgery. The investigators are interested in seeing if these programs can decrease stress and anxiety and improve mood and quality of life during this time. The investigators are also interested in looking at whether this type of short program affects certain markers in breast cancer cells, such as their growth and death rates, or in blood hormones such as insulin, which have been linked to breast cancer development. To be eligible, participants must not be planning to receive chemotherapy or hormone therapy before surgery.

Cymbalta for Aromatase Inhibitor-Related Bone & Joint Pain

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer (NCT01598298)

Summary

Bone and joint pain and stiffness are some of the most common side effects of the aromatase inhibitors (AI) used to treat hormone-sensitive tumors. Duloxetine hydrochloride (Cymbalta®) was approved in 2010 for treating chronic bone and muscle pain. Researchers believe Cymbalta may also be able to help decrease AI-related bone and joint pain and stiffness. This study is comparing Cymbalta to a placebo in postmenopausal women who are experiencing AI-related bone and joint pain and stiffness. To be eligible, participants must be currently taking Anastrozole (Arimidex®), Letrozole (Femara®), or Exemestane (Aromasin®) for at least 3 weeks but no longer than 1 year and plan to continue for at least 6 months.
This is a Phase III trial

Effect of CTAP101 in Breast Cancer Patients with Bone Metastases

Effect of CTAP101 Capsules on Serum Calcium and Plasma Intact Parathyroid Hormone and Vitamin D Metabolites in Patients With Advanced Breast or Prostate Carcinomas With Metastases to Bone and Receiving Ongoing Therapy With Denosumab or Zoledronic Acid (NCT02274623)

Summary

CTAP101 (calcifediol/Rayaldy™) was developed to treat patients with chronic kidney disease who have low levels of vitamin D. It is designed to increase vitamin D levels by increasing blood levels of 25-hydroxyvitamin D. Researchers think the drug, which comes in capsule form, may also help patients with breast cancer that has spread to the bone. Denosumab and Zoledronic acid (Zometa) are currently used along with chemotherapy to treat bone damage in metastatic breast cancer patients. This study is looking at the safety, best dose and efficacy of CTAP101 when it is given to women with metastatic breast cancer that has spread to the bone who are currently being treated with denosumab or Zometa. To be eligible, a woman must have been taking Zometa or denosumab for at least 3 months. This study is also recruiting men with metastatic prostate cancer.
This is a Phase I trial

Vitamin D When Starting on an Aromatase Inhibitor to Reduce Bone/Joint Pain

A Randomized, Controlled Trial of High Dose vs. Standard Dose Vitamin D for Aromatase-Inhibitor Induced Arthralgia in Breast Cancer Survivors (NCT01988090)

Summary

Aromatase inhibitors—anastrazole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®)—are routinely used to treat hormone-sensitive breast cancer in postmenopausal women. Joint/muscle pain is one of the most common side effects caused by these drugs. Vitamin D deficiency can result in a wide array of musculoskeletal issues. Some studies have suggested that vitamin D may help prevent or reduce aromatase inhibitor-related joint/muscle pain. This study is looking at the safety and effectiveness of two different doses of vitamin D for reducing joint/muscle pain in postmenopausal women with stage I to III breast cancer who are starting treatment with an aromatase inhibitor.
This is a Phase II trial

Effect of a Patient Navigation Program Developed for Latina/Hispanic Cancer Survivors

Improving Quality of Life Among Hispanic/Latino Breast, Colorectal & Prostate Cancer Survivors: A Randomized Control Trial of Patient Navigators Using the LIVESTRONG Cancer Navigation Services Program (NCT02275754)

Summary

Studies have found that Latinas/Hispanics generally have lower rates of cancer survival than women of other ethnic or racial groups. They also tend to have more health disparities and less access to care, which can affect their lives as cancer survivors. The LIVESTRONG Cancer Navigation Services Patient Navigator program offers peer navigators to help cancer patients following their cancer care. This study is comparing two ways of providing a patient navigation program that has been developed specifically for Latina/Hispanic survivors. It is also looking at whether the program improves cancer survivors' quality of life, cancer care and treatment follow-up. To be eligible, a woman must have been diagnosed with breast cancer within the past 15 months, have no evidence of metastatic disease and not be undergoing cancer treatment. This study also is enrolling patients who have completed treatment for prostate or colorectal cancer.

Mindfulness Based Theapy for Women with Breast Cancer & Their Partners

Mindfulness Based Couples Therapy for Breast Cancer Survivors: A Pilot Study (NCT02349217)

Summary

Mindfulness-based cognitive therapy is a psychological therapy designed to help people who are prone to recurring depression. It combines meditation, breathing exercises and stretching with cognitive therapy to help break negative thought patterns. This study is looking at the feasibility of conducting and the effect that a Mindfulness Based Cognitive Intervention has on relationship satisfaction, quality of life and immune system function in breast cancer survivors and their partners. To be eligible, couples must have lived together for at least 3 years.

Providing Support to Newly Diagnosed Patients

A Randomized Controlled Trial of the Impact of ICCAN on Cancer Treatment Completion and Quality of Life (NCT01742143)

Summary

Breast cancer treatment is most effective when a patient is able to follow her treatment plan. The Integrated Cancer Care Access Network (ICCAN) program provides individualized assistance to women being treated at New York City hospitals who are low-income or have other problems that may make it difficult for them to stay on their treatment. Women who take part in the program meet monthly with a facilitator to get assistance and support. This study is comparing the ICCAN program to the standard services provided in New York City hospitals, which include meeting with a social worker or a patient navigator. To take part, patients must speak English, Spanish, or Mandarin, have been diagnosed with breast cancer within the past month, and be currently receiving or scheduled to start chemotherapy or radiation.

Yoga to Reduce Fatigue During Radiation Therapy for Stage I-II Breast Cancer

A Randomized Study of the Effect of Yoga in Patients With Breast Cancer Receiving Radiation Therapy (NCT01985945)

Summary

Fatigue is a common side effect of radiation. Yoga has been shown to reduce fatigue as well as improve quality of sleep, physical vitality, and overall quality of life in women being treated for breast cancer. Eischens yoga incorporates ideas from movement theory and kinesiology and can be done by women with all body types and experience levels. It uses simplified poses that include sitting in a chair, standing and reclining. This study is looking at the effects that an 8-week Eischens yoga program has on women with stage I or II breast cancer who are receiving radiation therapy. To be eligible, participants must not have done yoga regularly in the last 6 months.

Low Level Laser Therapy With Conventional Lymphedema Treatment

The Effectiveness of Low Level Laser Therapy (LLLT)Combined With Complex Decongestive Therapy (CDT) in the Treatment of Breast Cancer-Related Lymphedema: A Double-Blind, Randomized, Placebo-Controlled Study (NCT01351376)

Summary

Lymphedema, a swelling of the arm or hand that may be accompanied by pain, numbness, and infection, can occur after breast cancer treatment. Lymphedema is typically treated with Complex Decongestive Therapy (CDT), which involves skin and nail care, compression sleeves or bandages, arm exercises, and a type of massage called manual fluid drainage. Researchers think that a new technique called Low-Level Laser Therapy (LLLT) that uses low-level lasers to alter cellular function might also be effective for treating lymphedema. This study will investigate whether LLLT in combination with CDT is more effective than CDT alone for treating women with upper arm lymphedema. To be eligible, individuals must have a diagnosis of lymphedema only in one arm, must be a breast cancer survivor, must not be receiving nor planning to receive radiation or chemotherapy, and must not have a body mass index (BMI) greater than 40.

Comparing Treatments for Hot Flashes Related to Arimidex®

A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Aromatase Inhibitors (NCT01530373)

Summary

Hot flashes are a common side effect of the anti-estrogen drugs called aromatase inhibitors. Researchers are hoping to find new treatment strategies for managing these hot flashes. (The most effective treatment, hormone replacement therapy, cannot be used by women who are taking an aromatase inhibitor.) The goal of this study is to compare solifenacin (Vesicare®), a drug that affects the function of smooth muscle and that researchers believe can help reduce hot flashes, to clonidine (Catapres®), a non-hormonal drug that is currently used to treat hot flashes. To be eligible, women must be currently taking anastrozole (Arimidex®) and must have been experiencing hot flashes at least 7 times per week for the past month.
This is a Phase II trial

Fluocinonide Cream for Hormone Therapy-Related Vaginal Dryness

Phase II Study of the Effect of the Topical Corticosteroid Fluocinonide in Breast Cancer Patients With Symptoms of Vaginal Dryness and Dyspareunia While on Adjuvant Endocrine Therapy. (NCT01422408)

Summary

Vaginal dryness and painful sexual intercourse can be a common side effect of treatment with hormone therapy. Fluocinonide cream is a topical steroid cream that is used to treat certain skin conditions; it can relieve itching, redness, dryness, inflammation, and discomfort. The goal of this trial is to determine whether fluocinonide cream can help to treat symptoms of vaginal dryness and painful sexual intercourse in individuals taking hormone therapy.
This is a Phase II trial

Mind-Body Program for Metastatic Cancer Patients

Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients (NCT00179387)

Summary

Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, and relationship strains are all potential "side-effects" of living with cancer and its treatment. Behavioral interventions have shown some success in relieving distress and improving quality of life among cancer patients. The purpose of this study is to find out if mind-body psychotherapy groups can help improve the physical and emotional well-being of people facing cancer. Participants must be on active cancer treatment.

Yoga-Based Cancer Rehabilitation Program

Evaluation of a Yoga-Based Cancer Rehabilitation Program (NCT00179348)

Summary

Yoga may help to improve quality of life for individuals with cancer because it incorporates elements of relaxation, social support, and exercise. Benefits of yoga include improved mood, energy, memory, concentration, physical fitness, and decreased pain. This study compares a 12-week yoga intervention to standard care on quality of life among patients with early-stage breast, lung, and colorectal cancer. Participants must have been diagnosed with new or recurrent cancer within the past 5 years.

Using Cryotherapy (Cold) to Reduce Taxol-Related Neuropathy in Hands and Feet

Prevention of Paclitaxel Neuropathy With Cryotherapy (NCT02230319)

Summary

Paclitaxel (Taxol®) is a chemotherapy drug that is commonly used to treat breast cancer. One of the known side effects of Taxol is neuropathy—nerve damage that causes numbness, tingling, or painful feelings in the hands and feet. Previous studies have suggested that cold temperatures (cryotherapy) can provide relief from pain as well as delay the development of neuropathy. Elasto gel™ Hypothermia mitts and slippers deliver cold temperature to hands and feet. The purpose of this study is to see if Elasto gel™ Hypothermia mitts and slippers decrease the risk of neuropathy developing in patients undergoing weekly Taxol treatments. To be eligible, a patient must be scheduled to receive Taxol before or after breast cancer surgery.
This is a Phase II trial

Naltrexone for Treating Fatigue That Develops During Radiation Therapy

Naltrexone Randomized Controlled Trial for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer (NCT02137252)

Summary

Fatigue is a common side effect of radiation therapy. Studies have shown that levels of beta-endorphins—a chemical the body makes in response to stress or injury—go up during radiation. An increase in beta-endorphins can cause fatigue. Naltrexone (ReVia®) is an FDA approved drug that interacts with beta-endorphins. Scientists think that naltrexone may help to reduce fatigue that develops in individuals undergoing radiation therapy. This study will compare naltrexone to a placebo in breast cancer patients who develop fatigue while undergoing radiation.
This is a Phase II trial

Laser Treatment for Blood Vessels Affected by Radiation

Quality of Life Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser (NCT01803516)

Summary

Radiation treatments for breast cancer can have long-term effects on the skin. Telangiectasia–dilated blood vessels that can look like a red rash on the skin— is a common side effect. Pulsed dye laser is a heat treatment that may cause the blood vessels to become smaller and less visible. The purpose of this study is to see if receiving pulsed dye laser treatment for radiation-induced telangiectasias affects a woman’s overall well-being. To be eligible, participants must have been treated for breast cancer with surgery and radiation and developed radiation-induced telangiectasia.

Dakin's Solution for Preventing Radiation Dermatitis During Breast Cancer Treatment

Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis (NCT02203565)

Summary

Radiation dermatitis is a skin condition where the affected skin becomes painful, red, itchy, and blistered. Dakin's solution is a strong antiseptic that is commonly used to prevent and treat skin and tissue infections. Researchers believe Dakin's solution may help reduce radiation dermatitis. This study is evaluating whether applying Dakin's solution before radiation will prevent radiation dermatitis in women being treated for breast cancer. To be eligible, patients must be scheduled for radiation therapy to the breast or chest wall.

Omega-3 Fatty Acids to Reduce Paclitaxel-Related Pain

A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome (NCT01821833)

Summary

Omega-3 fatty acids are nutrients that are essential for good health. Omega-3 fatty acids are not made by the body; they are obtained through foods or supplements. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat breast cancer. One of it most common side effects is pain. Studies suggest that omega-3 fatty acids may help decrease Taxol-related pain. This study is looking at whether omega-3 fatty acids are better than a placebo for reducing pain. To be eligible, participants must be scheduled to receive treatment with the chemotherapy drug paclitaxel.

Testosterone to Treat Joint Pain Caused by Arimidex or Femara

Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias (NCT01573442)

Summary

The aromatase inhibitors anastrozole (Arimidex) and letrozole (Femara) are widely used to treat hormone-sensitive tumors in postmenopausal women. Joint pain (arthralgia) is one of the most common side effects women on these drugs experience. Testosterone injections may help to reduce this pain. This trial is comparing the effectiveness of testosterone and a placebo for treating joint pain in postmenopausal patients with joint pain who are taking Arimidex or Femara.
This is a Phase III trial

Brief Behavioral Therapy to Improve Chemotherapy-Related Sleep Problems

Feasibility, Acceptability and Mechanisms of Brief Behavioral Therapy (BBT) for Sleep Problems During Chemotherapy: A Phase II Randomized Controlled Trial (NCT02002533)

Summary

Sleep problems are a common side effect of chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia and improve quality of life in cancer patients. Brief Behavioral Therapy (BBT) is a technique that consists of insomnia education, stimulus control, discouragement of napping and encouragement of exercise and sleep. Researchers are interested in seeing if BBT is an effective way to improve chemo-related sleep problems. This study is investigating whether BBT is more effective than the Healthy Eating Education (HEAL) program in improving sleep problems in patients with stage I-III breast cancer undergoing chemotherapy. To be eligible, participants must have sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy.
This is a Phase II trial

Breath Holding During Radiation Therapy to Protect the Heart

Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer (NCT01849614)

Summary

Breast cancer is often treated with a lumpectomy or mastectomy followed by radiation. Because the heart is so close to the left breast, radiation for left-sided breast cancer may increase a woman's risk of developing heart problems. Women who hold a deep breath while receiving radiation—a technique called Deep Inspiration Breath Hold (DIBH)—may be at less risk of developing future heart problems. This study is looking at whether DIBH reduces heart-related side effects. To be eligible, participants must have left-sided breast cancer and be planning to receive radiation therapy.

Sexual and Reproductive Health Study

Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma (NCT01788839)

Summary

Cancer and its treatment may affect sexual and reproductive health. To help researchers learn more about the problems women face, participants in this study will complete questionnaires on sexuality and pregnancy before, during, and after cancer treatment. The information will be used to help doctors identify which women are most likely to have early menopause or develop sexual problems during cancer therapy, or have difficulty getting pregnant after cancer treatment. To be eligible for this study a woman must be age 50 or younger, newly diagnosed with breast cancer, and planning on having, or within one month of starting, chemotherapy.

DHA for Reducing Risk of Recurrence for Triple Negative Disease

A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors (NCT01849250)

Summary

Docosahexaenoic acid (DHA) is an omega-3 fatty acid that is found in fatty fish and other foods. Laboratory studies have shown that DHA can inhibit some cancer-fueling chemicals produced by immune cells in the breast. This suggests that DHA may be able to help prevent a breast cancer recurrence. Women who have triple-negative breast tumors and who are overweight or obese are at increased risk of having a breast cancer recurrence. This study is comparing DHA to a placebo to learn more about the effect that DHA has on biological markers (biomarkers) linked to breast cancer risk. To be eligible for this study, participants must have triple negative breast cancer and be overweight or obese.
This is a Phase II trial

Coenzyme Q10 to Reduce Heart Damage from Adriamycin

Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer (NCT00976131)

Summary

Many women with breast cancer receive a chemotherapy regimen that includes the drug doxorubicin (Adriamycin®). However, women given doxorubicin may also experience some damage to their heart muscle. Coenzyme Q10 is a vitamin-like substance that helps cells convert the sugars in our food into energy that muscles can use. Researchers believe that Coenzyme Q10 may help to protect against heart damage during doxorubicin treatment. The goal of this trial is to study the safety and effectiveness of Coenzyme Q10 when taken during treatment with doxorubicin. To be eligible for this trial, participants must be scheduled to receive at least four cycles of doxorubicin.
This is a Phase I trial

A Vaginal Moisturizer for Women on an Aromatase Inhibitor

A Single-Arm Clinical Trial Investigating the Feasibility of a Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms (NCT01738152)

Summary

Aromatase inhibitors can cause or increase vaginal dryness. Hyaluronic acid (HLA) vaginal gel (HyaloGYN®) is an over-the-counter product that may be an effective non-hormonal treatment for vaginal dryness. This small study is looking at whether it is possible to conduct a larger study on whether HaloGYN can decrease vaginal dryness experienced by women who are taking an aromatase inhibitor after surgery for early-stage breast cancer. To be eligible, participants must be at least 3 months post-treatment but not more than 5 years post-treatment

Comparing Two Acupuncture Treatment Schedules for Treating Peripheral Neuropathy

A Phase I-II Study of Acupuncture for the Treatment of Chronic, Taxane-Induced Peripheral Neuropathy in Breast Cancer Survivors (NCT01815346)

Summary

Peripheral neuropathy, numbness and pain in the fingers or toes, is one of the most common side effects of chemotherapy. Studies have found that at least half of all patients who receive a taxane-based chemotherapy drug develop chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture involves inserting sterile, hair-thin needles into specific points on the skin to stimulate the nervous system. Previous studies have found that acupuncture can reduce pain associated with CIPN. The best treatment schedule for breast cancer survivors receiving acupuncture for CIPN is not known. This study is comparing the effectiveness of two acupuncture treatment schedules: two times a week for six weeks, and three times a week for four weeks. To be eligible, participants must have received a taxane-based chemotherapy drug and have neuropathy greater or equal to 2 on the Common Toxicity Criteria for Adverse Effects scale.
This is a Phase I-II trial

Vitamin D for Alaska Natives with Low Vitamin D Levels

Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer (NCT01787409)

Summary

Vitamin D protects bone and boosts the immune system. Studies suggest that people with low vitamin D levels may have a greater risk of developing cancer than those with higher vitamin D levels. Cholecalciferol (vitamin D3) is an artificial form of vitamin D. This study is investigating whether vitamin D3 improves survival in women newly diagnosed with breast cancer who have low levels of vitamin D. (Patients with other types of cancers are also being enrolled in this study.) To be eligible, breast cancer patients must be receiving treatment at the Alaska Native Medical Center, in Anchorage.

Using Patient Navigators to Address Racial Disparities in Cancer

Accountability for Cancer Care Through Undoing Racism and Equity (NCT01954641)

Summary

Statistics show that although a larger percentage of white Americans are diagnosed with breast and lung cancer, a larger proportion of African-Americans die from these diseases. Researchers are trying to find ways to reduce this disparity. Studies suggest that patient navigators who have comprehensive training in cancer issues, health literacy and communication techniques can benefit patients. The Accountability for Cancer Care through Undoing Racism and Equity (ACCURE) trial is comparing patients who work with patient navigators and patients who receive usual support and care. This study is enrolling white and African-American women and men who are being treated for stage I or II breast (or lung) cancer.

Reducing Pain, Fatigue & Sleep Disturbances in Patients with Advanced Cancer

A Brief Patient-Controlled Intervention for a Symptom Cluster in Advanced Cancer (NCT01954420)

Summary

Pain, fatigue, and sleep disturbances are common side effects and symptoms of advanced cancer that can have a negative effect on quality of life. Cognitive-behavioral strategies, like relaxation, distraction, and imagery, can help reduce these symptoms. Listening to guided imagery, relaxation exercises, and nature sound recordings on an MP3 player (an iPhone or similar device) is one method of using cognitive-behavioral therapy. This study is testing whether a patient-controlled cognitive-behavioral program available on an MP3 player can reduce pain, fatigue, sleep disturbances, and stress during cancer treatment. To be eligible, the patient must be receiving outpatient chemotherapy in 3-week cycles, with ≥ 1 drug administered intravenously, and be expected to receive at least 3 more cycles of chemotherapy after enrollment. This study is also recruiting patients with advanced lung, colorectal, prostate or gynecologic cancers.

An Exercise Program to Reduce Aromatase Inhibitor Related Side Effects

Pilot Trial of Aerobic and Resistance Exercise Training for the Primary Prevention of Musculoskeletal Side Effects From Aromatase Inhibitors in Postmenopausal Breast Cancer Patients (NCT01954706)

Summary

Aromatase inhibitors (AI) are used to treat postmenopausal women with hormone-sensitive tumors. Some of the most common side effects of these drugs are joint and muscle pain and fatigue. Exercise may help reduce these side effects. This study is comparing the benefits of a supervised exercise program to physical activity counseling and support in women who are taking an AI and experiencing mild fatigue.

Valproic Acid for Reducing Fluid Around the Lungs in Patients with Metastatic Disease

Randomized Phase II Double Blind Study of Valproic Acid (VPA) vs Placebo to Shorten Time of Indwelling Pleural Catheter (NCT01900730)

Summary

Patients with metastatic breast cancer can develop pleural effusion—a condition in which a large amount of fluid collects around the lungs. To treat the problem, the standard of care is to insert an indwelling pleural catheter to remove the fluid. Valproic acid (VPA) is used to treat epilepsy and migraine. Early studies suggest VPA can stop cancer cells from dividing and maturing. This may, in turn, decrease pleural fluid production. This study is investigating whether giving VPA along with the standard of care—an indwelling pleural catheter—reduces the amount of time the catheter is needed. To be eligible, participants must be scheduled to receive a pleural catheter.
This is a Phase II trial

A Walking Program to Reduce Joint Pain Caused by Aromatase Inhibitors

Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy (NCT01900418)

Summary

Aromatase inhibitors (AIs) are used to treat post-menopausal women with hormone-sensitive breast cancer. Some of the most common side effects associated with AIs are joint pain, stiffness, and achiness. The Arthritis Foundation's Walk with Ease (WWE) is a 6-month walking program that has been shown to reduce pain and improve overall health. This study is investigating the benefit of a WWE program tailored to the needs of breast cancer survivors on an AI.

Transcranial Magnetic Stimulation For Depression & Anxiety

A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Breast Cancer Patients With Depression and Anxiety (NCT01701284)

Summary

Cancer is associated with high rates of depression and anxiety. Yet cancer patients are at risk of experiencing negative drug interactions and side effects from antidepressant medications. Repetitive transcranial magnetic stimulation (rTMS) was recently approved by the FDA for treating drug-resistant Major Depressive Disorder. It involves placing on the scalp an electromagnet that generates magnetic field pulses roughly the strength of an MRI scan. Because it affects the brain directly, rTMS does not cause side effects and poses no potential for drug-drug interactions. This study is investigating the effectiveness of two different types of rTMS for reducing depression and anxiety in breast cancer patients who have been diagnosed with Major Depressive Disorder.

A Study of Aromatase Inhibitor-Related Side Effects: Pain, Fatigue and Difficulty Sleeping

Prospective Pilot Study Evaluating the Inter-relationships Between Sleep Disturbance, Fatigue, Pain, and Daytime Activity in Breast Cancer Patients Starting Aromatase Inhibitor Therapy (NCT01983995)

Summary

Aromatase inhibitors—anastrazole (Arimdex), letrozole (Femara) and exemestane (Aromasin) are used to treat postmenopausal women with hormone-positive breast cancer. Common side effects associated with these medications include pain, fatigue and difficulty sleeping. Researchers are interested in learning more about why these drugs cause these side effects. This study will look at the effect aromatase inhibitors have on pain, sleep quality, fatigue and daily activity in postmenopausal women with DCIS or stage I, II, or III breast cancer. To be eligible, a woman must be planning to start treatment with an aromatase inhibitor.

A Study Comparing Online and In-Person Pain Management Programs for Cancer Patients

An Accessible Mobile Health Behavioral Intervention For Cancer Pain (NCT02266017)

Summary

Many cancer patients experience pain from the cancer or its treatments. Studies have found that these patients can benefit from programs that increase their confidence in their ability to manage their pain. It is difficult for patients who do not live near a medical center to participate in a pain management program. Mobile health (mHealth) technologies that use a tablet computer or videoconferencing may be beneficial for these patients. This study is comparing the effectiveness of an mHealth program and a traditional in-person pain management program in patients who were diagnosed with breast cancer within the last year. This study also is enrolling patients with lung, prostate or colorectal cancer.

Low-Calorie Diet To Reduce Side Effects of Chemotherapy

A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy (NCT01802346)

Summary

Chemotherapy drugs attack cells that are rapidly dividing, which is why they are an effective cancer treatment. However, other cells in the body that also divide rapidly, like those in the bone marrow, mouth, intestines, and hair follicles, are also likely to be affected by chemotherapy—which can lead to side effects. It is possible that eating a low-calorie diet may reduce chemotherapy-related side effects as well as improve how the tumor responds to treatment. This trial is investigating whether patients with early-stage breast cancer who eat a controlled low-calorie diet will have fewer side effects and a better response to chemotherapy than breast cancer patients who eat a normal diet. To be eligible, participants must be planning to receive chemotherapy treatment of AC (doxorubicin plus cyclophosphamide). (This trial also is enrolling men with prostate cancer.)
This is a Phase II trial

Exercise and Counseling to Prevent Lymphedema

Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection (NCT00376597)

Summary

A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection. This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection.

A Diet Designed to Reduce Fatigue in Breast Cancer Survivors

Fatigue Reduction Diet in Breast Cancer Survivors (NCT01902745)

Summary

Many breast cancer survivors find that they continue to be very tired or weary after they complete breast cancer treatment. This problem, called persistent cancer-related fatigue (PCRF), is associated with decreased quality of life, decreased sleep quality, depression, chronic pain and impaired cognition. Researchers believe that a healthy diet that contains certain key nutrients may help reduce PCRF. This study is investigating whether a special diet can reduce PCRF in breast cancer survivors. To be eligible, patients must have completed treatment, other than hormone therapy, and be experiencing moderate or severe persistent fatigue.
This is a Phase I-II trial

A Study of Heavy Metals & Chemotherapy-Induced Peripheral Neuropathy

Assessing Heavy Metal Contributions to Neurotoxicity in Breast Cancer Patients Undergoing Adjuvant or Neoadjuvant Chemotherapy (NCT01982591)

Summary

Studies suggest that chemotherapy-induced peripheral neuropathy (CIPN)—numbness and tingling in the fingers and toes—affects between 20% and 50% of breast cancer patients. Doctors are trying to learn why some patients develop CIPN and other do not. Exposure to metals may occur through the diet, from medications, from the environment, or in the course of work or play. Chronic exposure to metal dusts has been linked to the development of neuropathy and other health problems. It is possible that the heavy metals in chemotherapy drugs may contribute to CIPN. Studying blood and urine samples taken from patients before and after chemotherapy treatments can help doctors learn whether previous metal exposure increases the risk for CIPN. This trial is looking at heavy metal exposure and CIPN in patients with stage I-III breast cancer who receive chemotherapy before and/or after surgery. To be eligible, patients must be receiving a cytotoxic chemotherapy that includes paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), or docetaxel (Taxotere®).

Metformin & Healthy Lifestyle Study for Overweight Survivors

Obesity-related Mechanisms and Mortality in Breast Cancer Survivors (NCT01302379)

Summary

Studies suggest that women who are overweight are at higher risk of experiencing a breast cancer recurrence. Adopting a healthy lifestyle that includes good nutrition and exercise may help with weight management. Metformin (Glucophage®) is an oral medication commonly used by people with diabetes to control insulin levels. Laboratory and epidemiological studies suggest that metformin may also have anticancer effects. This study will test the effect of metformin and healthy lifestyle education, alone or in combination, on biomarkers (proteins or molecules found in blood or tissue) that are linked to the risk of recurrence. To be eligible, participants must have a body mass index (BMI) of at least 25, and must not currently be taking insulin or any other antidiabetic drug.

Weight Loss Program To Prevent Recurrence in Overweight Women With Early Stage Disease

A Randomized Study Evaluating the Effect of a Remote-Based Weight Loss Program (POWER-remote) on Biomarkers in Women With Early Stage Breast Cancer (NCT01871116)

Summary

Research suggests that excess body weight may be a major risk factor for breast cancer. Weight loss is helpful for improving overall health, but may also decrease the chance of breast cancer coming back. The goal of this study is to see if women who have received treatment for Stage I-III breast cancer will lose weight on a dietary weight-loss program called Practice-based Opportunities for Weight Reduction (POWER). This program uses established behavioral techniques to achieve weight loss and involves online, telephone and email support. To be eligible, participants must have completed surgery and/or radiation therapy but may still be on anti-HER2 or hormone therapy.
This is a Phase II trial

Comparing Two Strategies for Quitting Smoking After a Cancer Diagnosis

Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial (NCT01871506)

Summary

Between 10 and 30 percent of people diagnosed with cancer are current smokers. Studies have found that people who continue smoking after a cancer diagnosis have shorter survival times, are more likely to have treatment-related complications, and are at increased risk of developing a second cancer. Currently, only about half of all cancer patients report having been asked about their tobacco use. This study is comparing two strategies to promote smoking cessation in people who are newly diagnosed with, or likely to have, cancer. To be eligible, participants must have smoked a cigarette, even a puff, in the past week and be willing to consider trying to quit smoking using counseling and/or smoking cessation medication. This study is enrolling women and men diagnosed or suspected of having breast or other types of cancers, receiving care at Massachusetts General Hospital Cancer Center or Memorial Sloan Kettering Cancer Center.
This is a Phase IV trial

A Program to Reduce Insomnia (Trouble Sleeping) Caused by Cancer or its Treatment

Brief Behavioral Intervention for Insomnia During Chemotherapy (NCT02165839)

Summary

Many women report that they experience insomnia--trouble sleeping--during their breast cancer treatment. A behavioral therapy program may help breast cancer patients cope with their insomnia. This study will compare a behavioral therapy program for insomnia to a healthy eating program in women being treated with chemotherapy or a biological therapy, like Herceptin, for early-stage breast cancer. To be eligible, a woman must have insomnia that began or got worse when she was diagnosed with cancer or began systemic treatment with chemotherapy or biological therapy.
This is a Phase III trial

Preventing Nausea and Vomiting From Chemotherapy

A Pilot Study to Evaluate the Efficacy of Fosaprepitant and Granisetron Transdermal System for the Prevention of Acute and Delayed Nausea and Vomiting in Breast Cancer Patients and to Identify Predictors of Response (NCT01649258)

Summary

Nausea and vomiting are common side effects of chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Fosaprepitant dimeglumine, which is delivered via IV, and the granisetron transdermal system patch are both antiemetic drugs. Researchers believe combining the two will make them more effective. This study is investigating how well fosaprepitant dimeglumine and the granisetron transdermal system patch work to prevent nausea and vomiting in breast cancer patients undergoing chemotherapy.

Botox to Reduce Pain Caused by Expanders During Reconstruction

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial (NCT01591746)

Summary

Breast reconstruction with implants is typically done in two stages. At the time of surgery, a temporary implant (tissue expander) is inserted, which over the course of several months is slowly filled with saline. A second surgery is then performed to replace the expander with a permanent implant. During expansion, patients often experience significant pain and discomfort. BTX-A (Botox) is currently used to reduce pain caused by migraine headaches and chronic tennis elbow as well as for post-operative pain control. This study will assess the safety and effectiveness of using Botox to reduce pain and improve physical well-being during tissue expansion. It is the first time Botox is being studied in breast cancer survivors who are having breast reconstruction with tissue expanders. To be eligible for this study, patients must be scheduled to have breast reconstruction following a skin-sparing or nipple-sparing mastectomy.
This is a Phase III trial

Varenicline for Cigarette Smoking Among Cancer Patients

Extended Duration Varenicline for Smoking Among Cancer Patients: A Clinical Trial (NCT01756885)

Summary

Stopping smoking is critical for persons who have been diagnosed with cancer because continued smoking after diagnosis has been found in prior research studies to be associated with decreased survival time, reduced effectiveness of cancer treatments, and decreased quality of life. This trial, which is located within the Department of Preventive Medicine in the Feinberg School of Medicine, is now offering a clinical research study that is evaluating a new smoking cessation intervention tailored to cancer patients and survivors. Eligible smokers will receive seven sessions of smoking cessation counseling and receive varenicline (Chantix), a U.S. Food and Drug Administration (FDA)-approved smoking cessation medication – all at no charge.
This is a Phase III trial

Effect of Vitamin D and Physical Activity on Bone Health

The Effect of High-Dose Vitamin D and Physical Activity on Bone Health in Breast Cancer Patients Receiving Hormonal Therapy (NCT01419730)

Summary

Some breast cancer treatments can speed up bone loss or cause women to lose more bone than they normally would. It is not known if bone loss in breast cancer survivors should be treated differently than bone loss in other women. This study is examining the effectiveness of vitamin D with and without physical activity (walking and progressive resistance exercise) in reducing bone loss in women who have been treated for breast cancer. The investigators will also study whether the physical activity program improves cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and balance. To be eligible, participants must be less than five years from the diagnosis of breast cancer and within six months of starting treatment with aromatase inhibitors.

A Study of How Exercise Affects Cells in Postmenopausal Breast Cancer Survivors

Deciphering the Breast Cancer Exercise Paradox: The Role of DNA Repair and Inflammation (NCT02235051)

Summary

Studies suggest that regular exercise may reduce the risk of a breast cancer recurrence. Researchers think this may be because exercise not only helps women maintain a healthy weight but also trains the body to repair DNA damage and respond more efficiently to inflammation. This study will look at the effect that an exercise program has on DNA and inflammation in postmenopausal breast cancer survivors. To participate, a woman must have been diagnosed with ER-positive breast cancer and have completed treatment within the last year.

Yoga for Aromatase Inhibitor-associated Joint Pain

Evaluating Yoga for Aromatase Inhibitor-associated Joint Pain in Women With Breast Cancer: A Pilot Study (NCT01951976)

Summary

Nearly half of of all breast cancer patients who are taking an aromatase inhibitor experience joint pain and stiffness. Studies have found that yoga can be effective in the treatment of joint pain. Iyengar yoga is a traditional form of Hatha yoga that consists of asanas (postures) and pranayama (breath control). It is routinely recommended to breast cancer patients to improve quality of life. The purpose of this study is to determine whether researchers should conduct a larger study on the effectiveness of yoga for relieving joint pain in women who are taking an aromatase inhibitor. To be eligible for this study, a woman must have joint pain that started or worsened after she began taking an aromatase inhibitor.

Preventing Heart Damage During Herceptin® Treatment

Lisinopril or Carvedilol Phosphate in Reducing Side Effects in Women With HER2-Positive Breast Cancer Receiving Trastuzumab (NCT01009918)

Summary

Trastuzumab (Herceptin®) is routinely used to treat HER2-positive breast cancer. However, Herceptin can cause heart damage and decrease heart function, especially when it is used in combination with certain chemotherapy drugs. Women who experience heart problems often stop taking Herceptin. They also typically start taking a beta blocker or an ACE inhibitor, two drugs that are commonly used to treat heart failure and that can reverse Herceptin-related heart damage.The goal of this trial is to test the effectiveness of taking lisinopril (a beta-blocker) or carvedilol (an ACE inhibitor) while on Herceptin to reduce the risk of heart damage. To be eligible, participants must be scheduled to receive Herceptin, with or without chemotherapy.
This is a Phase II trial

Exercise Program for Survivors

An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors (NCT01102985)

Summary

Regular physical activity can improve health by helping to control weight, maintaining healthy bones, and reducing the risk of many diseases, including heart disease, diabetes, and high blood pressure. Physical activity may also reduce the risk of breast and other cancers. The goal of this study is to determine the effect an exercise program has on the general health of postmenopausal women who have completed breast cancer treatment within the past three years.