Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

April 18, 2020 updated by: Ottawa Hospital Research Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H-1C4
        • The Ottawa Hospital-Integrated Cancer Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
No exercise measured
Experimental: Aerobic cardiovascular exercise program
Behavioral: Aerobic cardiovascular exercise program
Aerobic cardiovascular exercise program
Experimental: Resistance Exercise Program
Behavioral: Resistance Exercise Program
Resistance Exercise Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue- FACT F
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Canadian Cancer Trials Group

Investigators

  • Principal Investigator: Roanne Segal, OHRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria

November 10, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 18, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCIC 013232
  • OTT 02-04 (Other Identifier: OHRI)
  • CERHO 2002263-01H (Other Identifier: OHRI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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