Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

Not Applicable

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Behavioral: Resistance Exercise Program; Behavioral: Aerobic cardiovascular exercise program

• Registration Number: NCT00253916
• Lead Sponsor: Ottawa Hospital Research Institute

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

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-15
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-18
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance Exercise Program	Resistance Exercise Program	Resistance Exercise Program
Aerobic cardiovascular exercise program	Aerobic cardiovascular exercise program	Aerobic cardiovascular exercise program

Primary Outcome Measures

Name	Time	Method
Fatigue- FACT F	24 weeks

Secondary Outcome Measures

Name	Time	Method
Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL	24 weeks

Trial Locations

Locations (1)

The Ottawa Hospital-Integrated Cancer Program; 🇨🇦 Ottawa, Ontario, Canada