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

NCT ID: NCT02081612

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-12-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nutrition Education

Educational weight management group sessions alone

Group Type: ACTIVE_COMPARATOR

Nutrition Education

Intervention Type: BEHAVIORAL

12 educational weight management group session each addressing a different weight loss topic

Nutrition Education Plus Acupuncture

Educational weight management group sessions in addition to weight loss acupuncture

Group Type: ACTIVE_COMPARATOR

Nutrition Education

Intervention Type: BEHAVIORAL

12 educational weight management group session each addressing a different weight loss topic

Acupuncture

Intervention Type: PROCEDURE

12 weight loss acupuncture session using both body and auricular points.

Interventions

Nutrition Education

12 educational weight management group session each addressing a different weight loss topic

Intervention Type: BEHAVIORAL

Acupuncture

12 weight loss acupuncture session using both body and auricular points.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Amy Tiersten

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Tiersten, MD

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 14-0001

Identifier Type: -

Identifier Source: org_study_id