Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

This study has been completed.
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00253916
First received: November 10, 2005
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Prostatic Neoplasms
Behavioral: Aerobic cardiovascular exercise program
Behavioral: Resistance Exercise Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Fatigue- FACT F [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: June 2002
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253916

Locations
Canada, Ontario
The Ottawa Hospital-Integrated Cancer Program
Ottawa, Ontario, Canada, K1H-1C4
Sponsors and Collaborators
Ottawa Hospital Research Institute
NCIC Clinical Trials Group
Investigators
Principal Investigator: Roanne Segal OHRI
  More Information

No publications provided

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
Study First Received: November 10, 2005
Last Updated: May 29, 2012
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on April 17, 2014