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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02081612
Recruitment Status : Recruiting
First Posted : March 7, 2014
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):
Amy Tiersten, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: Nutrition Education Procedure: Acupuncture

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : September 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Maintenance of weight loss [ Time Frame: 24 months ]
  2. Recurrence of breast cancer [ Time Frame: 5 years ]
  3. quality of life [ Time Frame: 24 months ]
    Benefit on quality of life and well-being questionnaire

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02081612

Contact: Emilie Kane 212-824-7320

United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Emilie Kane    212-824-7320   
Principal Investigator: Amy Tiersten, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Study Director: Amy Tiersten, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Amy Tiersten, Associate Professor, Icahn School of Medicine at Mount Sinai Identifier: NCT02081612     History of Changes
Other Study ID Numbers: GCO 14-0001
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Breast Neoplasms
Weight Loss
Neoplasms by Site
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms