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Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00253916
Collaborator
Canadian Cancer Trials Group (Other)
121
Enrollment
1
Location
3
Arms
85
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic cardiovascular exercise program
  • Behavioral: Resistance Exercise Program
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Exercise in Men Receiving Radiation Therapy for Prostate Cancer: Effects on Fatigue, Toxicity, Body Composition, Muscular Fitness, Cardiorespiratory Fitness and Quality of Life.
Study Start Date :
Jun 1, 2002
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Arm

No exercise measured
Experimental: Aerobic cardiovascular exercise program

Aerobic cardiovascular exercise program

Behavioral: Aerobic cardiovascular exercise program
Aerobic cardiovascular exercise program
Experimental: Resistance Exercise Program

Resistance Exercise Program

Behavioral: Resistance Exercise Program
Resistance Exercise Program

Outcome Measures

Primary Outcome Measures

  1. Fatigue- FACT F [24 weeks]

Secondary Outcome Measures

  1. Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ottawa Hospital-Integrated Cancer Program Ottawa Ontario Canada K1H-1C4

Sponsors and Collaborators

  • Ottawa Hospital Research Institute
  • Canadian Cancer Trials Group

Investigators

  • Principal Investigator: Roanne Segal, OHRI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00253916
Other Study ID Numbers:
  • NCIC 013232
  • OTT 02-04
  • CERHO 2002263-01H
First Posted:
Nov 15, 2005
Last Update Posted:
Apr 21, 2020
Last Verified:
Apr 1, 2020
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Apr 21, 2020