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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498536
First Posted: December 23, 2011
Last Update Posted: October 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anne Swisher, West Virginia University
  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: None (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 Anne Swisher, West Virginia University:

Primary Outcome Measures:
  • weight loss [ Time Frame: 12 weeks ]
    aim for loss of 10% of BMI

  • quality of life [ Time Frame: 12 weeks ]
    Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires


Secondary Outcome Measures:
  • markers of inflammation [ Time Frame: 12 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498536


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

Responsible Party: Anne Swisher, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01498536     History of Changes
Other Study ID Numbers: H-22426
First Submitted: December 20, 2011
First Posted: December 23, 2011
Last Update Posted: October 30, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases