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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.

Dietary Intervention plus Chemotherapy Before Surgery for Early Stage Breast Cancer

CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer (NCT02827370)

Summary

To take part in this study, you must have been diagnosed with early stage breast cancer but not yet had surgery. This study is looking at whether a dietary intervention that will be determined based on your tumor's genomic characteristics changes the effect that chemotherapy given before surgery has on your cancer cells. Giving chemotherapy before surgery, called neoadjuvant treatment, allows researchers to study the effect a treatment had on the cancer cells after the tumor has been removed. Your tumor's genomic characteristics will be analyzed at the beginning of the study and after you have surgery.

A Diet Restricting Methionine in Early Stage Triple Negative Breast Cancer

A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer (NCT03186937)

Summary

To take part in this study, you must have recently been diagnosed with triple negative (ER-/PR-/HER2-) breast cancer and not yet had surgery or any other cancer treatments. This study is investigating the effect of reducing the amount of an amino acid called methionine in your diet has on cancer cells. High methionine foods include nuts, beef, lamb, cheese, turkey, pork, fish, shellfish, soy, eggs, dairy, and beans. Laboratory studies suggest reducing methionine levels can slow cancer cell growth. The cancer cells will be studied after they are removed during your breast cancer surgery.


This is a Phase 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.


This is a Phase II-III trial

Effect of Vitamin D on Breast Cells in Women With DCIS or LCIS

An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS (NCT02936999)

Summary

DCIS is a non-invasive breast cancer. Non-invasive means it has not spread out of the milk duct into the breast tissue. LCIS is an area of abnormal cell growth. Having DCIS or LCIS increases your risk for developing breast cancer. In this study, researchers will have women with LCIS or DCIS take vitamin D before surgery. The researchers will then study the tissue removed during surgery to see the effect the vitamin D has had on the breast cells.

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.

Yoga for Women Receiving Hormone Therapy or Chemo Before Surgery or Chemo After Surgery

The Role of Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer (NCT03262831)

Summary

To take part in this study, you must be newly diagnosed with stage I, stage II or stage III breast cancer and be planning to receive chemotherapy or hormone therapy before surgery or chemotherapy after surgery. You also must not currently be doing yoga regularly (at least once a month). This study is looking at the effects a personalized yoga program has on women who are being treated with hormone therapy or chemotherapy before surgery or chemotherapy after surgery. Yoga is a mind-body intervention that has been shown to reduce fatigue, reduce weight gain, and improve overall quality of life in breast cancer patients


This is a Phase I trial

Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients

RCT of Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients (NCT03683147)

Summary

To take part in this study you must be a woman who was diagnosed with metastatic breast cancer within the past five years and is currently receiving treatment at the Roswell Park Cancer Institute in Buffalo, New York. This study is evaluating an online mindfulness-based stress reduction treatment. Patients can enroll if they have a distress score of 4+, have an internet connection, and are not currently seeing a psychologist.

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.

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.

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

Effects of Hypnosis During Breast Cancer Surgery

Biobehavioral Effects of Hypnosis During Breast Cancer Surgery (NCT03012399)

Summary

To take part in this study, you must have recently been diagnosed with DCIS or stage I breast cancer and be planning to have breast surgery. This study is investigating a relaxation method called hypnosedation. Using this technique before and during breast cancer surgery may allow patients to avoid having general anesthesia. Hypnosedation is administered by a hypnotherapist, a mind-body specialist who uses words and images to help you relax during surgery.

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.

Reiki Therapy to Reduce Fatigue in Breast Cancer Patients On an Aromatase Inhibitor

Pilot Study on Energy Therapy or Massage to Reduce Fatigue in Breast and Prostate Cancer Patients on Hormone Therapy (NCT02758756)

Summary

To take part in this study, you must have stage I, II or III breast cancer, be on an aromatase inhibitor, and be experiencing extreme tiredness (fatigue). This study is investigating whether a type of touch therapy, called Reiki, can help reduce fatigue in breast cancer survivors who are taking an aromatase inhibitor. Reiki is a gentle touch therapy that its practitioners say helps promote healing and well-being by unblocking and balancing the flow of energy within the body.

Yoga for Chemotherapy Induced Peripheral Neuropathy in Survivors

Yoga for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Pilot Study (NCT03292328)

Summary

To take part in this study, you must be a breast cancer survivor and have moderate to severe peripheral neuropathy (numbness and pain in hands and feet) caused by your chemotherapy treatment. It must also be at least three months since you completed chemotherapy. This study will see if a yoga program reduces the pain and numbness in the hands and feet (peripheral neuropathy) that can be caused by certain types of chemotherapy.

Acupressure for Chinese Immigrant Breast Cancer Survivors in Los Angeles

Acupressure Intervention to Improve Fatigue and Physical Functioning of Chinese Immigrant Breast Cancer Survivors (NCT03091647)

Summary

To take part in this study, you must be a first-generation immigrant who speaks Chinese (Mandarin or Cantonese) living in or near Los Angeles, California. You must have been treated for DCIS or Stage I, II, or III breast cancer within the last 1 to 5 years and have moderate to severe levels of fatigue. This study is investigating whether using a Chinese-language video to teach patients how to self-administer acupressure helps improve cancer-related fatigue and quality of life better than the current standard of care.

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.


This is a Phase II trial

Mindfulness Meditation & Survivorship Education After DCIS & Stage I-III Breast Cancer

Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors (Pathways to Wellness) (NCT03025139)

Summary

To take part in this study, you must be have been diagnosed with DCIS or stage I, II, or III breast cancer within the last five years. Your diagnosis must have occurred when you were age 45 or younger. You must also show symptoms of depression on the study's screening questionnaire. This study is comparing the benefits of mindfulness meditation and survivorship education for reducing symptoms of depression in women who were diagnosed with DCIS or stage I, II or III breast cancer before age 45. Mindfulness meditation may help you change the way you respond to thoughts and life events. Survivorship education tailored to younger survivors may help help reduce stress and improve well-being and quality of life.

Acupuncture for Relieving Severe Post-Mastectomy Pain

Randomized-Controlled Trial of Acupuncture for Post-Mastectomy Pain Syndrome (NCT02754752)

Summary

To take part in this study, you must have had a mastectomy at least 4 months ago. You must also have had persistent pain in your chest area for at least 3 months. In addition, you must have seen your oncologist within the last 6 months. Electro-acupuncture is a two-step process. First, hair-thin needles are put into specific points in your body. Then, a mild electrical current is applied to the needles at a level that is comfortable to you. This study is investigating whether electro-acupuncture can help reduce pain women may experience after their mastectomy.


This is a Phase II trial

Omega-3 Fatty Acids for Preventing AI-Induced Pain for Women with Stage I-III Disease

Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation (NCT02831582)

Summary

To take part in this study, you must have had surgery for stage I, II or III breast cancer and be planning to start taking an aromatase inhibitor. This study is investigating whether omega-3 fatty acid supplements (fish oil) will help prevent bone and joint pain in women being treated with an aromatase inhibitor. Omega-3 fatty acids are not made by the body. They are obtained only through foods or supplements.

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