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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition Education
Acupuncture
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nutrition Education

Nutrition Education Plus Acupuncture

Arm Description

Educational weight management group sessions alone

Educational weight management group sessions in addition to weight loss acupuncture

Outcomes

Primary Outcome Measures

Weight Loss

Secondary Outcome Measures

Maintenance of weight loss
Recurrence of breast cancer

Full Information

First Posted
March 5, 2014
Last Updated
July 16, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02081612
Brief Title
Comparison of Nutrition Education Alone or With Acupuncture for Weight Loss in Breast Cancer Patients Post-Chemotherapy
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 Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 6, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Education
Arm Type
Active Comparator
Arm Description
Educational weight management group sessions alone
Arm Title
Nutrition Education Plus Acupuncture
Arm Type
Active Comparator
Arm Description
Educational weight management group sessions in addition to weight loss acupuncture
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education
Intervention Description
12 educational weight management group session each addressing a different weight loss topic
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
12 weight loss acupuncture session using both body and auricular points.
Primary Outcome Measure Information:
Title
Weight Loss
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Maintenance of weight loss
Time Frame
24 months
Title
Recurrence of breast cancer
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Tiersten, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Director
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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