Exercise in Men Receiving Radiation Therapy for Prostate Cancer.
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aerobic cardiovascular exercise program
Resistance Exercise Program
Sponsored by
About this trial
This is an interventional prevention trial for Prostatic Neoplasms
Eligibility 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
Sites / Locations
- The Ottawa Hospital-Integrated Cancer Program
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control Arm
Aerobic cardiovascular exercise program
Resistance Exercise Program
Arm Description
No exercise measured
Aerobic cardiovascular exercise program
Resistance Exercise Program
Outcomes
Primary Outcome Measures
Fatigue- FACT F
Secondary Outcome Measures
Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL
Full Information
NCT ID
NCT00253916
First Posted
November 10, 2005
Last Updated
April 18, 2020
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Cancer Trials Group
1. Study Identification
Unique Protocol Identification Number
NCT00253916
Brief Title
Exercise in Men Receiving Radiation Therapy for Prostate Cancer.
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Cancer Trials Group
4. Oversight
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
No exercise measured
Arm Title
Aerobic cardiovascular exercise program
Arm Type
Experimental
Arm Description
Aerobic cardiovascular exercise program
Arm Title
Resistance Exercise Program
Arm Type
Experimental
Arm Description
Resistance Exercise Program
Intervention Type
Behavioral
Intervention Name(s)
Aerobic cardiovascular exercise program
Intervention Description
Aerobic cardiovascular exercise program
Intervention Type
Behavioral
Intervention Name(s)
Resistance Exercise Program
Intervention Description
Resistance Exercise Program
Primary Outcome Measure Information:
Title
Fatigue- FACT F
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL
Time Frame
24 weeks
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roanne Segal
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital-Integrated Cancer Program
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H-1C4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
12721238
Citation
Segal RJ, Reid RD, Courneya KS, Malone SC, Parliament MB, Scott CG, Venner PM, Quinney HA, Jones LW, D'Angelo ME, Wells GA. Resistance exercise in men receiving androgen deprivation therapy for prostate cancer. J Clin Oncol. 2003 May 1;21(9):1653-9. doi: 10.1200/JCO.2003.09.534.
Results Reference
result
Learn more about this trial
Exercise in Men Receiving Radiation Therapy for Prostate Cancer.
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