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

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.
ClinicalTrials.gov Identifier: NCT01498536
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Breast Cancer Obesity Behavioral: aerobic exercise

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : July 2011
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Behavioral: aerobic exercise
    3 times per week for 12-weeks

Outcome Measures

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

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


Secondary Outcome Measures :
  1. markers of inflammation [ Time Frame: 12 weeks ]
    blood draws at beginning and end of study to analyze any effect on inflammation


Eligibility Criteria

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 Posted: December 23, 2011    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

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