Clinical trial NCT02081612: Comparison of Nutrition Education Alone or With Acupuncture for Weight Loss in Breast Cancer Patients Post-Chemotherapy
Official title: Comparison of Weight Loss Among Early Stage Breast Cancer Patients Post Chemotherapy: Nutrition Education in Combination With Weight Loss Acupuncture Vs. Nutrition Education Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight Loss
timeFrame: 24 weeks
Secondary outcomes:
measure: Maintenance of weight loss
timeFrame: 24 months
measure: Recurrence of breast cancer
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Amy Tiersten, MD
role: STUDY_DIRECTOR
References: