Prostate CancerNCT00834392
Exercise in Men With Prostate Cancer
A study testing Exercise in people with Prostate Cancer, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Dec 2010
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men aged 50 years or older
- diagnosed with adenocarcinoma prostate cancer
- will initiate and receive continuous ADT (luteinizing hormone releasing hormone agonist (LHRH) or combination of LHRH and anti-androgen) for at least 12 months after recruitment
- Patients will also consent to participating in the study.
Who cannot join
- severe cardiac disease (New York Heart Association class III or greater)
- angina
- severe osteoporosis
- uncontrolled hypertension (blood pressure > 160/95mm Hg)
- orthostatic blood pressure drop > 20mm Hg
- moderate to severe aortic stenosis
Show all 10Show fewer
- acute illness or fever
- uncontrolled atrial or ventricular dysrhythmias
- uncontrolled sinus tachycardia (> 120 beats per minute)
- uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness, severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, pathological lower limb fractures within 6 months, lower limb amputation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.
- Conditions
- Prostate Cancer
- Being tested
- Exercise
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Walking exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone health
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionDec 2010
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Investigators
- C. Ellen Lee, PhD, PT, Principal investigator, University of ManitobaY.K. James Lau, MD, PhD, Principal investigator, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834392
- Sponsor's protocol ID
- H2008:035
- Status last verified
- Jan 2011
- First submitted
- 2 Feb 2009
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee CE, Leslie WD, Lau YK. A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy. BMC Cancer. 2012 Mar 21;12:103. doi: 10.1186/1471-2407-12-103.
PubMed 22436542
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
- ClinicalTrials.gov ID
- NCT00834392
- Acronym / sponsor ID
- H2008:035
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Feb 2009 (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.
The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Exercise | Experimental | Behavioral: Exercise |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men aged 50 years or older
- diagnosed with adenocarcinoma prostate cancer
- will initiate and receive continuous ADT (luteinizing hormone releasing hormone agonist (LHRH) or combination of LHRH and anti-androgen) for at least 12 months after recruitment
- Patients will also consent to participating in the study.
Key exclusion criteria (10 listed)
- severe cardiac disease (New York Heart Association class III or greater)
- angina
- severe osteoporosis
- uncontrolled hypertension (blood pressure > 160/95mm Hg)
- orthostatic blood pressure drop > 20mm Hg
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 |
|---|---|---|
| ExerciseWalking exercise | Behavioural | Exercise |
Primary outcome
bone health
Time frame: baseline, 12 months
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 1 Feb 2011.
- Derived from this study: PubMed 22436542Lee CE, Leslie WD, Lau YK. A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy. BMC Cancer. 2012 Mar 21;12:103. doi: 10.1186/1471-2407-12-103.
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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.
C. Ellen Lee, PhD, PT principal investigator
University of Manitoba
Y.K. James Lau, MD, PhD principal investigator
CancerCare Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Prostate Cancer, run by University of Manitoba 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 4 inclusion and 10 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 1 Feb 2011. 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?
bone health (time frame: baseline, 12 months). 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 NCT00834392, 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 1 Feb 2011.