Breast Cancer
Conditions
Brief summary
This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy.
Detailed description
Obesity and weight gain are significant concerns for breast cancer survivors. Given the adverse consequences of weight gain after diagnosis, continued efforts to identify appropriate weight management interventions aimed at promoting overall health and long term survivorship are needed. In this study, the investigators will examine whether adding acupuncture to a nutrition education program for weight loss could improve short and long term weight loss among breast cancer survivors post treatment with chemotherapy.
Interventions
BEHAVIORALNutrition Education
12 educational weight management group session each addressing a different weight loss topic
PROCEDUREAcupuncture
12 weight loss acupuncture session using both body and auricular points.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman with a diagnosis of breast cancer, stage I, II, or III * Age ≥ 18 * ECOG performance status ≤ 1 * Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment. * BMI ≥ 30 * Adequate bone marrow and organ function as determined by the consenting/enrolling investigator * Signed informed consent * Any receptor status * Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations
Exclusion criteria
* Current chemotherapy or radiation therapy. Participants in study may still be receiving hormone or Herceptin treatment. * Diagnosis of metastatic breast cancer * Participation in other diet-based weight loss programs (ie. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.) * Current use of commercial or natural/herbal weight loss supplements * Major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery * Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin * Personal history of an eating disorder * Other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled HIV, Hepatitis B or C), or any psychiatric disorder that prohibits obtaining informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight Loss | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of weight loss | 24 months |
| Recurrence of breast cancer | 5 years |
Countries
United States
Outcome results
None listed