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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.

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.

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

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 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 

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 

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.

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

Cognitive-Behavioral Therapy to Decrease Worry & Insomnia in Women with Advanced Disease

Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors (NCT01929720)

Summary

Many breast cancer survivors experience short- and long-term side effects of treatment—including trouble sleeping, worry and anxiety—that may decrease their quality of life. Counseling can help reduce anxiety and trouble sleeping and improve quality of life. Cognitive behavior therapy (CBT) is a type of counseling that can help patients understand and gain control over the thoughts and feelings that influence behaviors. CBT is commonly used to treat phobias, depression, and anxiety. This trial is exploring whether CBT can help reduce worry, anxiety, and trouble sleeping in women and men with stage III or stage IV breast cancer. This study is also enrolling patients with other types of cancers.

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 certain types of chemotherapy. Paclitaxel (Taxol®), one of the commonly used breast cancer treatments, is 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 Taxol for inoperable locally advanced or metastatic breast cancer. It is possible that topical calcitriol may prevent or reduce the hair loss associated with Taxol. To be eligible, participants must be scheduled to receive Taxol, 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.

Compression Garments for Lymphedema

Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial (NCT00959985)

Summary

Women who have been treated for breast cancer may be at risk of developing lymphedema, which is characterized by a painful swelling of the arm. There currently are no clear treatment guidelines for lymphedema. One treatment option is the use of a compression sleeve to aid the flow of lymph fluid in the arm and prevent swelling. Another option, which is more intensive, involves wearing a compression sleeve as well as special compression bandages on the arm overnight. It is not known whether wearing a compression sleeve and bandages is more effective than the use of a compression sleeve alone. The purpose of this study is to evaluate the effectiveness of the use of compression garments in preventing or slowing the progression of lymphedema in breast cancer patients. To be eligible, participants must have mild or moderate lymphedema.
This is a Phase III trial

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.

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.

Physical Activity Program for Metastatic Patients

Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway (NCT01653366)

Summary

Studies have shown that physical activity can help reduce the risk of a cancer recurrence. Physical activity may also slow cancer growth in patients who already have metastatic tumors. This study is investigating whether a program that asks patients to set a walking goal will result in increased physical activity. It is also looking at if increasing physical activity decreases BMI, improves quality of life, increases time to progression or affects biological markers associated with tumor growth. To be eligible, participants must be at least 4 weeks from last treatment for metastatic disease and greater than one year from completing adjuvant therapy.

A Program to Improve Quality of Life in Breast Cancer Survivors

The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors (NCT01734499)

Summary

Researchers have been developing programs designed to improve the quality of life of breast cancer survivors. However, studies have found that the positive effects of these program may not last long after the program is completed. This study is investigating whether a class called the "Change Cycle Work Shop" that focuses on teaching life skills that have been shown to have a long-lasting impact will benefit breast cancer survivors. This study is open only to patients who are being treated at the Texas Tech University Health Sciences Center-Breast Center of Excellence from January 2010 onward.

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.

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.

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

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

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.

Couples Counseling for Breast Cancer Patients

Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer (NCT00940277)

Summary

Breast cancer treatment can be physically and emotionally demanding for both patients and their partners. The goal of this study is to determine the value of two counseling interventions developed to reduce the psychological distress on patients and their partners during and after the breast cancer experience. Both patients and their partners will participate in the counseling interventions. Couples must be married or co-habitating.

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.

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

Acupuncture to Reduce Chemotherapy Related Side Effects in Early-Stage Breast Cancer

The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients (NCT01996410)

Summary

Acupuncture is a treatment that involves inserting sterile, hair-thin needles into specific points on the skin. Studies have found that acupuncture can help relieve fatigue, hot flashes, nausea, vomiting, and pain. Researchers believe this is because acupuncture stimulates the nervous system. This study is investigating whether acupuncture can reduce symptoms associated with chemotherapy, such as nausea, vomiting, fatigue, anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and peripheral neuropathy. To be eligible, a patient must be planning to receive chemotherapy to treat stage I - III breast cancer.

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.

Flexeril for Aromatase Inhibitor-Related Sleep Problems & Fatigue

UMCC 2013.051: Prospective Pilot Study Evaluating the Use of Cyclobenzaprine for Treatment of Sleep Disturbance, Fatigue, and Musculoskeletal Symptoms in Aromatase Inhibitor-treated Breast Cancer Patients (NCT01921296)

Summary

Fatigue and insomnia (trouble sleeping) are two of the side effects that can affect breast cancer survivors who are on an aromatase inhibitor. Sleeping pills often do not help decrease these side effects. Cyclobenzaprine (Flexeril) is a muscle relaxant that has been used to improve sleep in patients with pain disorders. This study is investigating whether Flexeril can improve sleep and reduce fatigue in breast cancer survivors taking an aromatase inhibitor.
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, lymphedema 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.

Stress Reduction to Improve Quality of Life After a Recurrence

A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence (NCT01764789)

Summary

Women who learn they have had a breast cancer recurrence have experienced a stressful event. Mindfulness-Based Stress Reduction is a structured program that uses mindfulness (a type of meditation and yoga) to treat different conditions. It is thought to be effective for alleviating pain and improving physical and emotional well being. This study is looking at whether mindfulness-based stress reduction can improve quality of life in women who have been diagnosed with a breast cancer recurrence. To be eligible, participants must have a new diagnosis of recurrent breast cancer. (This study also is open to women who have a new diagnosis of a recurrent gynecologic cancer.)

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

Healing the Incision Made During a Nipple-Sparing Mastectomy

A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy (NCT01796977)

Summary

During a nipple-sparing mastectomy the breast tissue is removed through a small incision below the nipple. This allows the surgeon to spare all of the breast skin, including the nipple and areola. A dressing is put over the incision to aid with healing. OxyGenesys Dissolved Oxygen Dressing (ODOD) is a new type of dressing that provides oxygen bubbles directly to the site of the incision. These oxygen bubbles may help the incision to heal better. The goal of this study is to evaluate the effectiveness of ODOD for healing the incision made during a nipple-sparing mastectomy. To be eligible for this trial, a woman must be planning to have a bilateral nipple-sparing mastectomy with immediate breast reconstruction because she has breast cancer or because she carries a BRCA genetic mutation.

Ayurveda: An Alternative Approach to Cancer Survivorship

A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II (NCT01488123)

Summary

Ayurveda medicine is a healing oriented approach to care that incorporates both conventional and alternative therapies. For breast cancer survivors who experience a reduced quality of life as result of their diagnosis and treatment, it may provide an alternative option for post-treatment care. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. The purpose of this study is to determine whether a four-month Ayurvedic intervention will improve the quality of life of recent breast cancer survivors. To be eligible, participants must be over 1 month and less than 12 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy). Participants must also have received chemotherapy and be in complete remission.

Aleve or Claritin w/ Neulasta to Reduce Bone Pain During Chemo

Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim (NCT01712009)

Summary

One of the most common side effects of chemotherapy is short-term damage to the bone marrow that interferes with its ability to make blood cells. This is called bone marrow suppression (or myelosuppression) and it can cause bone pain. This study is investigating whether using the non-steroidal anti-inflammatory drug naproxen (Aleve®) or the anti-histimine loratadine (Claritin®) can reduce the incidence and/or severity of bone pain in breast cancer patients receiving chemotherapy.
This is a Phase II trial

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

Smoking Cessation Prior to Mastectomy & Reconstruction

Treatment of Tobacco Dependence in Breast Cancer Patients Scheduled for Mastectomy/Reconstructive Surgery: A Randomized Trial of Varenicline (Chantix) (NCT01532232)

Summary

Breast cancer patients who smoke are at greater risk for treatment complications, especially if they are scheduled for surgery. The purpose of this study is to investigate the effectiveness and impact of varenicline, a prescription medicine also known as Chantix®, in helping breast cancer patients quit smoking. All patients will also receive smoking cessation counseling provided by a tobacco treatment specialist. To be eligible, participants must have smoked an average of 10 cigarettes per day for the past year and be planning to have a mastectomy with reconstruction at Memorial Sloan Kettering Cancer Center in New York City.

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

Reducing Risk of Lymphedema from Axillary Node Dissection

Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation (NCT00932035)

Summary

A potential risk associated with Axillary Lymph Node Dissection (ALND) is lymphedema, a painful swelling of the arm that is caused by faulty drainage of the lymph nodes. Axillary Reverse Mapping (ARM) is a procedure that uses an injectable blue dye to evaluate the ways in which fluid drains through the lymph node system. Researchers believe that using ARM to identify and preserve lymphatic channels and nodes draining the arm when performing an ALND may reduce lymphedema, resulting in an improved quality of life.
This is a Phase I-II trial

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.

Calcium and Magnesium for Preventing Taxane-Induced Neuropathy

Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy in Earlier Stage Breast Cancer (NCT01682499)

Summary

Neuropathy is the medical term for pain or discomfort in the hands and feet caused by damage to the nerves of the peripheral nervous system. It is a potential side effect of the taxane drugs used in many chemotherapy regimens. There are currently no effective ways to treat or prevent taxane-related neuropathy. Previous studies have found that calcium and magnesium infusions can decrease the incidence and intensity of neuropathy symptoms. This study will evaluate the feasibility of giving an intravenous calcium and magnesium (Ca/Mg) infusion to help prevent taxane-induced neuropathy to patients with early stage breast cancer who are receiving paclitaxel (Taxol®).
This is a Phase I 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

Reducing Sexual Pain in Heterosexual Breast Cancer Survivors

Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer (NCT01539317)

Summary

Pain during sexual intercourse is a common side effect following the treatment of breast cancer. It is believed that this pain may arise in the vulvar vestibule (the entrance to the vagina). The goal of this study is to determine whether applying lidocaine, a non-hormonal drug, to this area of the vulva, will reduce pain during intercourse. To be eligible, participants must be menopausal, have been diagnosed with breast cancer at least two years ago, be experiencing pain with intercourse, and be in a stable, heterosexual partnership of at least 5 years.
This is a Phase III 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

A Program to Help Breast Cancer Survivors Return to Work

Reducing Work Disability in Breast Cancer Survivors (NCT01799031)

Summary

It can be difficult to work while being treated for breast cancer—because of pain, fatigue, or other treatment-related side effects. As a result, breast cancer patients may need to work fewer hours or take time off both during and after treatment. Web sites that provide information about symptom management may help breast cancer survivors facing these issues. The WISE web-based program is designed to help breast cancer survivors manage their symptoms, identify workplace problems and risks, and implement modifications to minimize stress, discomfort and injury. This study is investigating whether women who use the WISE web-based program are able to return to work sooner or work more hours than women who do not take part in the program. To be eligible, participants must have been employed at the time of their breast cancer diagnosis and be within six months of completion of their active treatment.

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

Intellectual Impairment in Women With Breast Cancer

Assessment and Treatment of Cognitive Deficits in Breast Cancer (NCT00896324)

Summary

Breast cancer and its treatment may cause changes in a woman's ability to think, learn, and remember. Gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment. The goal of this trial is to study intellectual impairment in women with breast cancer who may or may not have received chemotherapy. This trial is also comparing the effectiveness of two intervention programs designed to prevent or reduce cognitive difficulties associated with chemotherapy treatment. The researchers are also enrolling women who have never had breast cancer to participate in this study.
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.

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

Cognitive Rehab Intervention Group for Stage I - III Survivors

Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors (NCT01540955)

Summary

Many breast cancer survivors experience short- and long-term side effects of treatment that may decrease their quality of life. Some of the most common side effects involve mental tasks such as attention, memory, and multi-tasking. Referred to as cognitive-related problems, these are often described as "chemo brain." This study is designed to see whether a 5-week group-based cognitive rehabilitation intervention can improve cognitive functioning. Each study volunteer will be given an EEG test before and after the intervention program, as the researchers are also interested in studying whether this test can be used to document improvement.
This is a Phase II 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

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

Health Problems Following a Breast Cancer Diagnosis and Treatment

A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer Without Germline BRCA Mutations: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker (NCT01982448) (NCT00027118)

Summary

Breast cancer and its treatments can affect women in many different ways. Researchers are interested in learning more about the physical problems, functional limitation, and loss of independence women face following a breast cancer diagnosis and treatment. In this study, women who have been diagnosed with breast cancer will be interviewed and examined every three to six months through two years after the completion of treatment. The researchers will compare the women with breast cancer to healthy women who had a breast biopsy that was negative for breast cancer. This will allow them to study the effects breast cancer and its treatment have over time. To be eligible, women must be treated at the National Naval Medical Center in Bethesda, MD.

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.

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.

Effects of Exercise & A Good Diet in Postmenopausal Survivors

Impact of Nutrition and Exercise on Glucose Metabolism, Inflammation, and Body Composition in Older Breast Cancer Survivors (NCT01151488)

Summary

Studies suggest that physical activity and good nutrition can reduce the risk of developing a wide range of health problems. Side effects associated with cancer and its treatments may result in breast cancer survivors becoming less active or not eating a healthy diet. The purpose of this study is to see the effects that resistance training, diet changes, and vitamin D and calcium supplements have on fatigue, muscle weakness and wasting, and impaired physical functioning (poor balance and walking) in postmenopausal breast cancer survivors. To be eligible for this study, a woman must be a nonsmoker, not have had her period for at least 12 months, and not be taking part in any structured physical activity more than two times a week.

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

Treatment for Tamoxifen Side Effects

Tamoxifen in Women With Breast Cancer and in Women at High-Risk of Breast Cancer Who Are Receiving Venlafaxine, Citalopram, Escitalopram, Gabapentin, or Sertraline (NCT00667121)

Summary

Tamoxifen (Nolvadex®) is widely used for the prevention and treatment of breast cancer. In some patients, tamoxifen produces hot flashes or depression, which may require treatment with one of the following drugs: venlafaxine (Effexor®), citalopram (Celexa®), escitalopram (Lexapro®), gabapentin (Neurontin®) or sertraline (Zoloft®). This clinical trial is studying levels of tamoxifen in the blood of women with or at high risk for breast cancer who are considering one of the above drugs to counter depression or hot flashes. By studying these samples, doctors hope to learn more about how these drugs may influence the level of tamoxifen in the blood.

A New Treatment for the Management of Neutropenia

Phase 2, Open-Label, Dose-Ranging Study of HM10460A or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophophamide (NCT01724866)

Summary

Neutropenia is an abnormally low count of neutrophils, a type of white blood cell that helps fight off infections. About half of all people who receive chemotherapy develop some degree of neutropenia. Pegfilgrastim (Neulasta®) is the drug that is currently used to prevent neutropenia. HM10460A is a new medication that can be given less frequently and at a lower dose than Neulasta. This study is comparing HM10460A to Neulasta to see which does a better job of reducing severe neutropenia. To be eligible, participants must be a candidate for docetaxel (Taxotere®) and cyclophosphamide (Cytoxan®) chemotherapy.
This is a Phase II trial

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.

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.

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

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

Assessing Changes in the Brain Before & After Chemotherapy

Feasibility Study of Vascular and Cognitive Assessments During Adjuvant Chemotherapy for Breast Cancer (VASCOG) (NCT01483196)

Summary

Some types of breast cancer treatment can affect a patient's memory, resulting in a condition often referred to as "chemo brain" or "chemo fog." Two tests that allow researchers to assess changes occurring in the brain–Transcranial Doppler ultrasound (TCD) and Magnetic Resonance Imaging (MRI)—may help us to better understand why chemo brain occurs. In this trial, patients will have TCD and MRI before chemotherapy has started and after it has ended so that the researchers can assess what brain changes may have occurred during this time period.

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.

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.

Cold Cap for Preventing Hair Loss During Chemotherapy

Clinical Performance, Efficacy and Safety of the DigniCap™ System, a Scalp Hypothermia System, in Preventing Chemotherapy Induced Alopecia in Patients With Early Stage Breast Cancer (NCT01831024)

Summary

Hair loss is a side effect of many chemotherapy drugs. The Dignicap™ system uses cold to numb the scalp during chemotherapy. The cold reduces blood flow to the scalp, which may keep the chemotherapy drug from harming the hair follicles. This study is evaluating the effectiveness and tolerability of using the DigiCap System to prevent hair loss during chemotherapy. To be eligible, women must be planning to have chemotherapy before or after surgery as part of their breast cancer treatment.

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 Walking Program for Older Patients Receiving Chemotherapy

Feasibility of an Evidence-based Walking Program in a Sample of Cancer Patients >60 Years of Age Undergoing Cytotoxic Chemotherapy (NCT01789983)

Summary

People who spend time walking over the course of their chemotherapy treatments may have an improved quality of life during their cancer care. This is a pilot study testing a medium-intense walking program called Walk With Ease in cancer patients age 60 and older who are starting chemotherapy. Researchers will look at biomarkers of aging in the blood and also measure how many participants complete the program. Results from this study will be used to help design future studies of the Walk With Ease program. This study is enrolling women and men scheduled to receive chemotherapy for any type of 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.

F-627 to Prevent Neutropenia (Low White Blood Cell Count)

A Phase II, Randomized, Multi-Centre, Open-Label, Active-Controlled, Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (NCT01648322)

Summary

Chemotherapy can cause neutropenia--a dangerously low white blood cell count that increases the risk of infection. Pegfilgrastim (Neulasta®) is given along with chemotherapy to keep neutropenia from developing. F-627 is a new drug that may help the body make white blood cells faster than Neulasta does. This study is comparing the effectiveness and safety of two different doses of F-627 with Neulasta. To be eligible, participants must be diagnosed with stage II or III breast cancer and scheduled to have four cycles of the chemotherapy regimen taxotere and cyclophosphamide (TC).
This is a Phase II trial

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

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.

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.

Effect of Exercise in Postmenopausal Breast Cancer Survivors

Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile (NCT01582685)

Summary

Studies suggest that exercise can reduce the risk of a breast cancer recurrence. However, the biological reasons for this are not yet known. One theory is that exercise increases angiostatic factors in the blood that not only decrease fat tissue but reduce the growth of microscopic residual disease after surgery, thereby decreasing the risk of recurrence. This study is investigating whether exercise increases blood levels of angiostatic factors and decreases angiogenic factors that might support tumor growth. To be eligible, participants must have a body mass index (BMI) > 25.

Studying the Effect of Exercise on Breast Cells in High-Risk Women

Pilot Feasibility Study of the Use of Random Periareolar Fine Needle Aspiration Exercise Induced Changes in Breast Tissue (NCT01961128)

Summary

Studies suggest that exercise can decrease breast cancer risk, but precisely how exercise affects breast cells to reduce this risk is not known. Breast random fine needle aspiration is a procedure that allows researchers to study the cells that line the breast ducts, where most breast cancer begins. During the procedure, cells are drawn out with a small needle after the skin is numbed with a local anesthetic. In this study, researchers will use random fine needle aspiration to study changes that occur in the breast cells of women who are at high risk for breast cancer and who are taking part in an exercise program.