Effect of Diet and Exercise in Breast Cancer Survivors (F4F tri neg)
Primary Purpose
Breast Cancer, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aerobic exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- ER/PR/HER2neu negative breast cancer
- at least 3 months after end of treatment
- BMI at least 25
Exclusion Criteria:
- stage IV cancer
Sites / Locations
- West Virginia University
Outcomes
Primary Outcome Measures
weight loss
aim for loss of 10% of BMI
quality of life
Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires
Secondary Outcome Measures
markers of inflammation
blood draws at beginning and end of study to analyze any effect on inflammation
Full Information
NCT ID
NCT01498536
First Posted
December 20, 2011
Last Updated
October 29, 2013
Sponsor
West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT01498536
Brief Title
Effect of Diet and Exercise in Breast Cancer Survivors
Acronym
F4F tri neg
Official Title
Fit for the Fight: Effect of a Multidisciplinary Diet and Exercise Program on Body Weight, Quality of Life and Inflammation in Survivors of Triple-negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
3 times per week for 12-weeks
Primary Outcome Measure Information:
Title
weight loss
Description
aim for loss of 10% of BMI
Time Frame
12 weeks
Title
quality of life
Description
Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
markers of inflammation
Description
blood draws at beginning and end of study to analyze any effect on inflammation
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ER/PR/HER2neu negative breast cancer
at least 3 months after end of treatment
BMI at least 25
Exclusion Criteria:
stage IV cancer
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
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Effect of Diet and Exercise in Breast Cancer Survivors
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