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Clinical Trials/NCT00253916
NCT00253916
Completed
Not Applicable

Exercise in Men Receiving Radiation Therapy for Prostate Cancer: Effects on Fatigue, Toxicity, Body Composition, Muscular Fitness, Cardiorespiratory Fitness and Quality of Life.

Ottawa Hospital Research Institute1 site in 1 country121 target enrollmentJune 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostatic Neoplasms
Sponsor
Ottawa Hospital Research Institute
Enrollment
121
Locations
1
Primary Endpoint
Fatigue- FACT F
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Androgen Deprivation Therapy is a commonly used treatment for men with Prostate Cancer. Unfortunately this can lead to functional decline, fatigue, increased body fatness, loss of lean body tissue and impaired QOL. Previous research has demonstrated the exercise can may reduce fatigue and improve QOL in men on ADT. This study will evaluate whether aerobic versus resistance exercise over a 24 week period of training will reduce morbidity and improve QOL in men receiving radiation plus or minus ADT with curative intent

Detailed Description

A total of 220 men with a diagnosis of prostate cancer, scheduled to receive radiation will be recruited. The study is a parallel 3-group design with groups stratified for intended duration of ADT ( greater or less than 12 weeks) and random assignment to aerobic, resistance or Wait List control groups. The dependent variable of interest will fatigue measured at 24 weeks by the 13 item FACT-Fatigue. Dependent variables of secondary interest will be toxicity of radiation, body composition, muscular fitness, cardio-respiratory fitness, metabolic fitness, and prostate specific QOL. All exercise sessions will be performed 3 times per week at the Ottawa Hospital regional Cancer Center

Registry
clinicaltrials.gov
Start Date
June 2002
End Date
July 2009
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Prostate Cancer
  • Radiation Therapy with curative Intent

Exclusion Criteria

  • Contraindication to exercise
  • Uncontrolled hypertension
  • Uncontrolled Cardiac Disease
  • Uncontrolled psychotic condition
  • Unable to obtain informed consent

Outcomes

Primary Outcomes

Fatigue- FACT F

Time Frame: 24 weeks

Secondary Outcomes

  • Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL(24 weeks)

Study Sites (1)

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