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

July 16, 2019 updated by: Amy Tiersten, Icahn School of Medicine at Mount Sinai

Comparison of Weight Loss Among Early Stage Breast Cancer Patients Post Chemotherapy: Nutrition Education in Combination With Weight Loss Acupuncture Vs. Nutrition Education Alone

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutrition Education
Educational weight management group sessions alone
Behavioral: Nutrition Education
12 educational weight management group session each addressing a different weight loss topic
Active Comparator: Nutrition Education Plus Acupuncture
Educational weight management group sessions in addition to weight loss acupuncture
Behavioral: Nutrition Education
12 educational weight management group session each addressing a different weight loss topic
Procedure: Acupuncture
12 weight loss acupuncture session using both body and auricular points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight Loss
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Maintenance of weight loss
Time Frame: 24 months
24 months
Recurrence of breast cancer
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Study Director: Amy Tiersten, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 6, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 14-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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