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

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

December 20, 2011
December 23, 2011
October 30, 2013
July 2011
August 2013   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01498536 on ClinicalTrials.gov Archive Site
markers of inflammation [ Time Frame: 12 weeks ]
blood draws at beginning and end of study to analyze any effect on inflammation
Same as current
Not Provided
Not Provided
 
Effect of Diet and Exercise in Breast Cancer Survivors
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
This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Obesity
Behavioral: aerobic exercise
3 times per week for 12-weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
30
August 2013
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01498536
H-22426
No
Not Provided
Not Provided
Anne Swisher, West Virginia University
West Virginia University
Not Provided
Not Provided
West Virginia University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP