Comparison of Nutrition Education Alone or With Acupuncture for Weight Loss in Breast Cancer Patients Post-Chemotherapy

Mount Sinai Health System

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Acupuncture; Behavioral: Nutrition Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02081612

GCO 14-0001

Details and patient eligibility

About

This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy.

Full 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.

Enrollment: 53 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Nutrition Education

Active Comparator group

Description:

Educational weight management group sessions alone

Treatment:

Behavioral: Nutrition Education

Nutrition Education Plus Acupuncture

Active Comparator group

Description:

Educational weight management group sessions in addition to weight loss acupuncture

Treatment:

Behavioral: Nutrition Education

Procedure: Acupuncture