Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2009-07-31

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

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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

Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Arm

No exercise measured

Group Type NO_INTERVENTION

No interventions assigned to this group

Aerobic cardiovascular exercise program

Group Type EXPERIMENTAL

Aerobic cardiovascular exercise program

Intervention Type BEHAVIORAL

Aerobic cardiovascular exercise program

Resistance Exercise Program

Group Type EXPERIMENTAL

Resistance Exercise Program

Intervention Type BEHAVIORAL

Resistance Exercise Program

Interventions

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Aerobic cardiovascular exercise program

Intervention Type BEHAVIORAL

Resistance Exercise Program

Intervention Type BEHAVIORAL

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

Eligible Sex

MALE

Accepts Healthy Volunteers

No