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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Amy Tiersten, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT02081612
First received: March 5, 2014
Last updated: March 6, 2014
Last verified: March 2014

March 5, 2014
March 6, 2014
March 2014
March 2015   (final data collection date for primary outcome measure)
Weight Loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02081612 on ClinicalTrials.gov Archive Site
  • Maintenance of weight loss [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Recurrence of breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • 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.
 
Recruiting
40
March 2020
March 2015   (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
Female
18 Years and older
No
Contact: Emilie Kane 212-824-7320 emilie.kane@mssm.edu
United States
 
NCT02081612
GCO 14-0001
No
Amy Tiersten, Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Study Director: Amy Tiersten, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
March 2014

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