NCT00253916

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

7.1 years

First QC Date

November 10, 2005

Last Update Submit

April 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fatigue- FACT F

    24 weeks

Secondary Outcomes (1)

  • Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL

    24 weeks

Study Arms (3)

Control Arm

NO INTERVENTION

No exercise measured

Aerobic cardiovascular exercise program

EXPERIMENTAL

Aerobic cardiovascular exercise program

Behavioral: Aerobic cardiovascular exercise program

Resistance Exercise Program

EXPERIMENTAL

Resistance Exercise Program

Behavioral: Resistance Exercise Program

Interventions

Aerobic cardiovascular exercise program

Aerobic cardiovascular exercise program

Resistance Exercise Program

Resistance Exercise Program

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate Cancer
  • Radiation Therapy with curative Intent
  • ADT

You may not qualify if:

  • Contraindication to exercise
  • Uncontrolled hypertension
  • Uncontrolled Cardiac Disease
  • Uncontrolled psychotic condition
  • Unable to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital-Integrated Cancer Program

Ottawa, Ontario, K1H-1C4, Canada

Location

Related 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. doi: 10.1200/JCO.2003.09.534.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Roanne Segal

    OHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 15, 2005

Study Start

June 1, 2002

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations