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
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: 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
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014