Exercise in Men Receiving Radiation Therapy for Prostate Cancer: Effects on Fatigue, Toxicity, Body Composition, Muscular Fitness, Cardiorespiratory Fitness and Quality of Life.
N/A
N/A
Male
Prostatic Neoplasms
Trial Information
Exercise in Men Receiving Radiation Therapy for Prostate Cancer: Effects on Fatigue, Toxicity, Body Composition, Muscular Fitness, Cardiorespiratory Fitness and Quality of Life.
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
Inclusion Criteria:
- Prostate Cancer
- Radiation Therapy with curative Intent
- ADT
Exclusion Criteria:
- Contraindication to exercise
- Uncontrolled hypertension
- Uncontrolled Cardiac Disease
- Uncontrolled psychotic condition
- Unable to obtain informed consent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Fatigue- FACT F
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
Roanne Segal
Investigator Role:
Principal Investigator
Investigator Affiliation:
OHRI
Authority:
Canada: Health Canada
Study ID:
NCIC 013232
NCT ID:
NCT00253916
Start Date:
June 2002
Completion Date:
July 2009
Related Keywords:
- Prostatic Neoplasms
- Neoplasms
- Prostatic Neoplasms
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