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Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

O

Ottawa Hospital Research Institute

Status

Completed

Conditions

Prostatic Neoplasms

Treatments

Behavioral: Resistance Exercise Program
Behavioral: Aerobic cardiovascular exercise program

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT00253916
CERHO 2002263-01H (Other Identifier)
OTT 02-04 (Other Identifier)
NCIC 013232

Details and patient eligibility

About

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

Full 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

Enrollment

121 patients

Sex

Male

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

121 participants in 3 patient groups

Control Arm
No Intervention group
Description:
No exercise measured
Aerobic cardiovascular exercise program
Experimental group
Description:
Aerobic cardiovascular exercise program
Treatment:
Behavioral: Aerobic cardiovascular exercise program
Resistance Exercise Program
Experimental group
Description:
Resistance Exercise Program
Treatment:
Behavioral: Resistance Exercise Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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