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
  Purpose

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 Intervention
Breast Cancer
Behavioral: Nutrition Education
Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081612

Contacts
Contact: Emilie Kane 212-824-7320 emilie.kane@mssm.edu

Locations
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    emilie.kane@mssm.edu   
Principal Investigator: Amy Tiersten, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Study Director: Amy Tiersten, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Amy Tiersten, Associate Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT02081612     History of Changes
Other Study ID Numbers: GCO 14-0001
Study First Received: March 5, 2014
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014