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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.
ClinicalTrials.gov Identifier: NCT02081612
Recruitment Status : Recruiting
First Posted : March 7, 2014
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):

March 5, 2014
March 7, 2014
July 21, 2017
September 2014
June 2018   (Final data collection date for primary outcome measure)
Weight Loss [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT02081612 on ClinicalTrials.gov Archive Site
  • Maintenance of weight loss [ Time Frame: 24 months ]
  • Recurrence of breast cancer [ Time Frame: 5 years ]
  • quality of life [ Time Frame: 24 months ]
    Benefit on quality of life and well-being questionnaire
Same as current
Not Provided
Not Provided
Comparison of Nutrition Education Alone or With Acupuncture for Weight Loss in Breast Cancer Patients Post-Chemotherapy
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.
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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Breast Cancer
  • 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.
  • Active Comparator: Nutrition Education
    Educational weight management group sessions alone
    Intervention: Behavioral: Nutrition Education
  • Active Comparator: Nutrition Education Plus Acupuncture
    Educational weight management group sessions in addition to weight loss acupuncture
    • Behavioral: Nutrition Education
    • Procedure: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2020
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact: Emilie Kane 212-824-7320 emilie.kane@mssm.edu
United States
GCO 14-0001
Not Provided
Not Provided
Amy Tiersten, Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
Not Provided
Study Director: Amy Tiersten, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP