Prostatic NeoplasmsNCT00253916
Exercise in Men Receiving Radiation Therapy for Prostate Cancer.
A study testing Aerobic cardiovascular exercise program and Resistance Exercise Program in people with Prostatic Neoplasms, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Aerobic cardiovascular exercise program and Resistance Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2002to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prostate Cancer
- Radiation Therapy with curative Intent
- ADT
Who cannot join
- Contraindication to exercise
- Uncontrolled hypertension
- Uncontrolled Cardiac Disease
- Uncontrolled psychotic condition
- Unable to obtain informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Ottawa Hospital-Integrated Cancer Program
Ottawa, Ontario, K1H-1C4
About this study
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.
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
Read the 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
- Conditions
- Prostatic Neoplasms
- Being tested
- Aerobic cardiovascular exercise program, Resistance Exercise Program
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic cardiovascular exercise programBehavioural
Aerobic cardiovascular exercise program
Resistance Exercise ProgramBehavioural
Resistance Exercise Program
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | No exercise measured |
| Aerobic cardiovascular exercise program | Experimental | Aerobic cardiovascular exercise program Receives: Behavioral: Aerobic cardiovascular exercise program |
| Resistance Exercise Program | Experimental | Resistance Exercise Program Receives: Behavioral: Resistance Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue- FACT F
Measured: 24 weeks
Secondary outcomes (1)
Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJun 2002
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Trials Group
- Responsible party
- Sponsor
- Investigators
- Roanne Segal, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253916
- Sponsor's protocol ID
- NCIC 013232
- Other IDs
- OTT 02-04, CERHO 2002263-01H
- Status last verified
- Apr 2020
- First submitted
- 10 Nov 2005
- Last updated
- 21 Apr 2020
- Results posted
- No
Publications
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.
PubMed 12721238
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00253916
- Acronym / sponsor ID
- NCIC 013232
- Conditions
- Prostatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Cancer Trials Group
- Study start
- Jun 2002
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –No exercise measured |
| Aerobic cardiovascular exercise program | Experimental | Behavioral: Aerobic cardiovascular exercise programAerobic cardiovascular exercise program |
| Resistance Exercise Program | Experimental | Behavioral: Resistance Exercise ProgramResistance Exercise Program |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Prostate Cancer
- Radiation Therapy with curative Intent
- ADT
Key exclusion criteria (5 listed)
- Contraindication to exercise
- Uncontrolled hypertension
- Uncontrolled Cardiac Disease
- Uncontrolled psychotic condition
- Unable to obtain informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic cardiovascular exercise programAerobic cardiovascular exercise program | Behavioural | Aerobic cardiovascular exercise program |
| Resistance Exercise ProgramResistance Exercise Program | Behavioural | Resistance Exercise Program |
Primary outcome
Fatigue- FACT F
Time frame: 24 weeks
1 secondary outcome
Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Results publication: PubMed 12721238Segal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roanne Segal principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic cardiovascular exercise program and Resistance Exercise Program in people with Prostatic Neoplasms, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue- FACT F (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.