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Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00253916
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Prostatic Neoplasms Behavioral: Aerobic cardiovascular exercise program Behavioral: Resistance Exercise Program

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  (Clinical Trial)
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 : June 2002
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253916


Locations
Canada, Ontario
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
More Information

Publications:
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00253916     History of Changes
Other Study ID Numbers: NCIC 013232
OTT 02-04
CERHO 2002263-01H
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases