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Complementary and Alternative Medicine

Complementary and alternative medicine (CAM) may have a role in breast cancer care after a breast cancer diagnosis. Clinical trials are investigating which CAM therapies are effective during treatment or can improve quality of life for breast cancer survivors.

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.

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

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

Summary

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

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.

Vitamin D to Prevent Breast Cancer in Healthy Women Who Are Not High Risk

Prostaglandin Inhibition to Prevent Breast Cancer (NCT01769625)

Summary

Some studies have suggested that inflammation in the body may increase breast cancer risk. Vitamin D helps the body absorb and maintain the right amount of calcium in the blood. It also helps control cell growth and reduce inflammation. Celecoxib (Celebrex®) is a drug that reduces inflammation by inhibiting an enzyme called COX-2. The purpose of this study is to determine if vitamin D alone or in combination with Celebrex decreases levels of certain biological markers (biomarkers) thought to be related to breast cell changes and breast cancer risk. This trial is enrolling healthy women with a normal risk of developing breast cancer.
This is a Phase I-II trial

Effect of Olive Oil on Breast Density in High-Risk Women

A Pilot Study of Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention In Women At High Risk Of Breast Cancer (NCT02068092)

Summary

Studies have shown that women with dense breast tissue are at increased risk for developing breast cancer. Laboratory studies have found that hydroxytyrosol--a major component of olive oil--is a powerful antioxidant with very low toxicity in the human body, even at high doses. Researchers think that hydroxytyrosol may reduce dense breast tissue. This study will evaluate the effect that hydroxytyrosol has on the breast tissue of women who are at high risk for developing breast cancer.

The Effect of Vitamin D & Celebrex® on Breast Cancer Biomarkers

Breast Cancer Prevention Using Synergistic Prostaglandin Inhibitors (The Vitamin D/Celecoxib Study) (NCT01425476)

Summary

Some studies have suggested that inflammation in the body may increase breast cancer risk. Vitamin D helps the body absorb and maintain the right amount of calcium in the blood. It also helps control cell growth and reduce inflammation. Celecoxib (Celebrex®) is a drug that reduces inflammation by inhibiting an enzyme called COX-2. The purpose of this study is to determine if vitamin D alone or in combination with Celebrex decreases levels of certain biological markers (biomarkers) thought to be related to breast cell changes and breast cancer risk. To be eligible, a woman must be at an increased risk for developing breast cancer because she has been diagnosed with precancerous breast changes, has a five-year Gail Model risk score that is 1.66% or higher, or has a personal or family history of breast cancer.
This is a Phase I-II trial

Flaxseed to Reduce Risk in High-Risk Premenopausal Women

Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer (NCT01276704)

Summary

Secoisolariciresinol digluscside (SDG) is a lignan (plant-based estrogen) that is found in flaxseed. Laboratory studies have shown that plant-based estrogens can fit into the estrogen receptor, where they act as weak estrogens in the breast and uterus. By blocking the estrogen receptor, plant-based estrogens may be able to protect cells from the stronger estrogens produced by a woman's body. Brevail® is a supplement that contains SDG made from flaxseed. The purpose of this study is to see whether Brevail® reduces the risk of breast cancer in high-risk premenopausal women. To be eligible, women must be high risk due to one of the following: a first or second degree relative with breast cancer diagnosed before the age of 60; a prior history of atypical hyperplasia, LCIS, or multiple prior breast biopsies regardless of histology; high mammographic density; prior or current evidence of atypia; or a known BRCA 1 or 2 mutation.
This is a Phase II trial

Effect of Tumeric on Breast Tissue in Obese, High-Risk Women

Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial (NCT01975363)

Summary

Laboratory studies suggest that tumeric (curcumin) may have anti-cancer effects. This may be because tumeric can reduce inflammation, which has been linked to cancer growth. Researchers think that tumeric may reduce inflammation in fat tissue and breast tissue, which may decrease breast cancer risk. This pilot study is looking at the effect that tumeric has on the breast tissue of obese women who are at high risk for breast cancer.

Reducing the Risk of Breast Cancer with Omega-3 Fatty Acids and Weight Loss

Randomized Pilot Trial of Omega-3 Fatty Acids or Placebo in Peri- or Post-Menopausal Women at High Risk for Breast Cancer Undergoing a Weight Loss Intervention (NCT02101970)

Summary

Studies have found that women who are overweight are at increased risk for developing breast cancer. This may be because obesity is linked to chronic inflammation in breast tissue, which has been shown to increase breast cancer risk. Omega-3 fatty acids cannot be made by the body and must be obtained from food or supplements. Studies suggest that omega-3 fatty acids have the ability to resolve chronic inflammation. This study is investigating whether adding a high dose of omega-3 fatty acids to a weight loss program reduces inflammation in the breast in women who are at high risk for developing breast cancer.
This is a Phase II trial

Exercise Programs in Healthy, High-Risk Young Women

Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer (NCT00892515)

Summary

Studies suggest that exercise may decrease a woman's risk of developing breast cancer. It is not yet known whether certain types of exercise are more likely to reduce risk than others, or whether low-intensity exercise and high-intensity exercise have the same effects. The goal of this trial is to compare the effects of a low-intensity and high-intensity exercise program on hormone levels, breast density, and body composition in healthy women between the ages of 18 and 35 who are at increased risk of developing breast cancer.

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

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

Summary

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

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

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

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

Summary

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

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

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

Vitamin D to Treat Anti-Estrogen Therapy Side Effects in Women with Stage IV Breast Cancer

Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D) (NCT02186015)

Summary

Anti-estrogen therapies are used to treat ER+ and/or PR+ breast cancer. Side effects of these therapies include pain, fatigue, mood and sleep disturbances. Researchers think that vitamin D supplements may help reduce these side effects. However, vitamin D can also lead to excess calcium in the blood, which could increase estrogen production in the body. This study will monitor blood calcium and vitamin D levels to identify the best dose and effectiveness of a vitamin D supplement for reducing anti-estrogen related side effects in women with metastatic breast cancer.
This is a Phase I trial

Evaluating A Weight-Loss Program for Overweight Breast Cancer Survivors

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

Summary

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

Lifestyle Changes During Radiation Therapy to Improve Outcomes

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

Summary

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

Nutrition Education and Acupuncture for Weight Loss After Chemotherapy

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

Summary

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

Mindfulness Based Theapy for Women with Breast Cancer & Their Partners

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

Summary

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

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.

Omega-3 Fatty Acids (Fish Oil) to Reduce Fatigue in Breast Cancer Survivors

Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue (NCT02352779)

Summary

Omega-3 fatty acids (fish oil) are nutrients that are essential for good health that are obtained through food or supplements. Scientists think that omega-3 fatty acids may help reduce cancer-related fatigue in breast cancer survivors. This study is comparing the safety and effectiveness of two different doses of an omega-3 fatty acid supplement to a placebo for reducing cancer-related fatigue in breast cancer survivors. To be eligible, patients must have completed standard adjuvant treatment (surgery, chemotherapy, radiation) and be experiencing cancer-related fatigue.
This is a Phase II trial

Exercise and Counseling to Prevent Lymphedema

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

Summary

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

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

Brief Behavioral Intervention for Insomnia During Chemotherapy (NCT02165839)

Summary

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

An Online Weight Loss & Exercise Program for Survivors

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

Summary

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

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.

Diet and Exercise Program for Overweight Survivors

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

Summary

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

Increasing Physical Activity During Chemotherapy for Early Stage Breast Cancer

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

Summary

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

Aerobic Exercise for Women with Metastatic Breast Cancer

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

Summary

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

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.

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.

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.

Yoga for Breast Cancer Patients Undergoing Chemotherapy

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

Summary

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

Acupuncture For Treating Post-mastectomy Pain, Nausea and Anxiety

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

Summary

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

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.

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

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

Summary

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

Massage to Reduce Anxiety Before Breast Cancer Surgery

Utility of Preoperative Massage in Breast Surgery Patients (NCT01667328)

Summary

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

Acupressure for Persistent Cancer Related Fatigue

Acupressure for Persistent Cancer Related Fatigue (NCT01281904)

Summary

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

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

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

Summary

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

Yoga for Breast (and Ovarian) Cancer Survivors

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

Summary

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

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

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

Summary

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

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

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

Summary

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

Massage to Reduce Pain and Increase Mobility After Breast Surgery

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

Summary

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

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.

Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

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

Summary

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

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

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.

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

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

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

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

Summary

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

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

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

Summary

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

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

LIVESTRONG Exercise Program For Cancer Survivors

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

Summary

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

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.

Acupuncture for Chronic Lymphedema

Acupuncture for Chronic Lymphedema: A Randomized Wait-list Controlled Trial (NCT01706081)

Summary

Breast cancer treatment can result in lymphedema, a painful swelling of the arm or hand. It can develop right after breast cancer treatment or weeks, months or even years later. A small, preliminary study conducted by these researchers found that more than one-third of the 33 patients studied had at least a 30 percent reduction in lymphedema following acupuncture treatment, with no serious side effects occurring during the study or in the six months after treatment ended. This study, which is enrolling a larger group of patients, will allow the researchers to continue to study if acupuncture can reduce lymphedema and how long the effects last after acupuncture treatments ends. To be eligible, participants must have lymphedema for at least 6 months and no more than 5 years.
This is a Phase II trial

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

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

Summary

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

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.

Yoga-Based Cancer Rehabilitation Program

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

Summary

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

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

Prevention of Paclitaxel Neuropathy With Cryotherapy (NCT02230319)

Summary

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

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.

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

Comparing Two Acupuncture Treatment Schedules for Treating Peripheral Neuropathy

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

Summary

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

An Exercise Program to Reduce Aromatase Inhibitor Related Side Effects

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

Summary

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

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.

Green Tea for Newly-Diagnosed DCIS

A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS) (NCT01060345)

Summary

Studies have shown that women with ductal carcinoma in situ (DCIS) have inflammation in the breast tissue surrounding their DCIS. This finding supports the idea that there is a link between inflammation and cancer. Researchers are studying green tea because both laboratory and epidemiology studies suggest that green tea may have anti-cancer and anti-inflammatory effects. The purpose of this study is to find molecular signs (biomarkers) that will help researchers better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).

Effect of CTAP101 in Breast Cancer Patients with Bone Metastases

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

Summary

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

Identifying Tissue Biomarkers to Study Omega-3 Fatty Acids for Breast Cancer Prevention

Omega-3 Fatty Acids and ERPR(-) and HER-2/Neu(+/-) Breast Cancer Prevention (NCT02295059)

Summary

Omega-3 fatty acids are found in fatty fish and other foods. DHA (docosahexaenoic acid) and EPA (eicosapentanoic acid) are omega-3 fatty acids. Researchers think omega-3 fatty acids may decrease cancer risk by reducing inflammation in the body and interfering with tumor cell growth. In this study, researchers will take tissue samples from women receiving two different doses of DHA and EPA in order to identify tissue biomarkers they can use in future studies that will evaluate the use of omega-3 fatty acids for breast cancer prevention. To be eligible, a woman must have a tumor that is ER/PR-negative and have completed breast cancer treatment.
This is a Phase I trial

Acupuncture to Reduce Side Effects in Breast Cancer Patients Receiving Taxol

Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients: A Pilot Study (NCT02364726)

Summary

Acupuncture is a traditional Chinese medical technique that involves inserting very thin needles into specific points on the body. Studies suggest it can help reduce certain types of pain. Paciltaxel (Taxol®) is a chemotherapy drug used to treat breast cancer. One of the side effects associated with Taxol is numbness, tingling, or burning pain in the hands or feet. (This side effect is called peripheral neuropathy.) Acupuncture may be able to reduce this pain. This study is investigating whether weekly acupuncture reduces pain in women who are receiving a chemotherapy regimen that includes weekly Taxol before or after surgery to treat stage I-III breast cancer.

Glutamine Supplements to Prevent Radiation-Related Side Effects

Glutamine for the Prevention of Radiation Toxicity in Subjects Undergoing Breast (NCT02012608)

Summary

Radiation used to damage cancer in your body can also damage healthy cells. Glutamine is an amino acid that helps fuel cell division. Previous studies have found that glutamine supplements may help prevent or treat skin toxicity by promoting DNA or tissue damage repair to healthy cells. This study will compare the effects of glutamine and a placebo in patients with stage I or stage II breast cancer who are having accelerated partial breast radiation following a lumpectomy (breast conserving surgery) for their breast cancer treatment.
This is a Phase II trial

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

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.

Effect of Omega-3 Fatty Acids Given Before Surgery on Breast Cancer Cells

A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma (NCT01869764)

Summary

Omega-3 fatty acids are essential nutrients for good health. They are not made by the body, and are obtained only through foods or supplements. Laboratory studies suggest omega-3 fatty acids can slow the growth of cancer cells. This study is comparing the effect of omega-3 fatty acids to the effect of a placebo on breast cancer cells. To be eligible, participants must be planning to have breast cancer surgery (lumpectomy or mastectomy) at least 7 days from the start of the study.
This is a Phase II trial