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Clinical Trials/NCT01498536
NCT01498536CompletedNot Applicable

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

West Virginia University1 site in 1 country28 target enrollmentStarted: July 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
weight loss
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • markers of inflammation(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anne Swisher

Associate Professor

West Virginia University

Study Sites (1)

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