Effect of Diet and Exercise in Breast Cancer Survivors (F4F tri neg)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Swisher, West Virginia University
ClinicalTrials.gov Identifier:
NCT01498536
First received: December 20, 2011
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.


Condition Intervention
Breast Cancer
Obesity
Behavioral: aerobic exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    aim for loss of 10% of BMI

  • quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires


Secondary Outcome Measures:
  • markers of inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    blood draws at beginning and end of study to analyze any effect on inflammation


Enrollment: 28
Study Start Date: July 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: aerobic exercise
    3 times per week for 12-weeks
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498536

Locations
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
  More Information

No publications provided

Responsible Party: Anne Swisher, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01498536     History of Changes
Other Study ID Numbers: H-22426
Study First Received: December 20, 2011
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014