Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

Prostatic Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253916
• Other study ID #: NCIC 013232
• Secondary ID: OTT 02-04CERHO 2
• Status: Completed
• Phase: N/A
• Start date: June 2002
• Est. completion date: July 2009

Study information

• Verified date: April 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital-Integrated Cancer Program	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Cancer Trials Group

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue- FACT F		24 weeks
Secondary	Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL		24 weeks