Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Behavioral: Aerobic cardiovascular exercise program
* Behavioral: Resistance Exercise Program


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>No exercise measured | |
| Experimental: Aerobic cardiovascular exercise program<br>Aerobic cardiovascular exercise program | Behavioral: Aerobic cardiovascular exercise program<br>* Aerobic cardiovascular exercise program<br>|
| Experimental: Resistance Exercise Program<br>Resistance Exercise Program | Behavioral: Resistance Exercise Program<br>* Resistance Exercise Program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue- FACT F |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL |  | 24 weeks |