Prostate CancerNCT00868868
Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy
An observational study of Prostate Cancer, run by Groupe de recherche en Urologie de la Mauricie at 1 site in Canada.
Trial summary
A randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in prostate cancer patients treated with androgen deprivation therapy. The investigators want to demonstrate if there are less side effects of hormonal therapy and better quality of life in patients who made regular exercise. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Sep 2011
- Phase
- Observational
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male subjects aged 18 years or older with histological confirmed prostate cancer.
Who may be able to join
- 18 years of age or older
- Histologically proven prostate cancer
- Treatment plan is to administer long term ADT (androgen deprivation therapy).
- Patient must currently be treated with ADT for at least 2 weeks before enrollment in trial, and for no more than 6 months. Patient treated with a maximum androgen blockade strategy, combining an anti-androgen agent with a LHRH analog agent are admissible to this protocol, but not patients treated only with an anti-androgen agent alone.
- Written informed consent to participate in the trial.
Who cannot join
- Known hypersensitivity to Zoladex, Casodex (if applicable), or any component of these product, or to other similar agents
- Severe cardiac disease (New York Heart Association class III or greater)
- Severe lung disease
- Uncontrollable pain
- Unstable bone lesion
- Any co-morbidity restraining the patient's ability to walk alone or to modify his walking habits (eg Parkinson's disease, advanced multiple sclerosis, leg amputation, ...)
Show all 9Show fewer
- Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
- Any contraindication to undertake the 6-minutes walk test (unstable angina or myocardial infarction during the previous month, a resting heart rate of more than 180, systolic blood pressure of more than 180, and a diastolic pressure of more than 100). The patient must have his cardiovascular conditions stabilized and controlled before enrollment in the trial.
- Unwillingness or incapacity to consent to trial participation.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Groupe de Recherche en Urologie de la Mauricie
Trois-Rivières, G9A 3V7
Dr Alain Maillette, Urologist, 819-373-4141, grum@cgocable.ca
Dr Alain Maillette, Urologist
About this study
Official title: Pedometer and Exercise Study: A Randomized Trial Evaluating the Use of a Pedometer and Brief Exercise Coaching in Prostate Cancer Patients Treated With Androgen Deprivation Therapy.
A randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in prostate cancer patients treated with androgen deprivation therapy. The investigators want to demonstrate if there are less side effects of hormonal therapy and better quality of life in patients who made regular exercise.
Read the detailed description
To evaluate effectiveness of regular exercise and well-being all patients will complete questionnaires about sexual function (IIEF-15) and quality of life. We will also perform at each visits anthropometrics measurement of waist, leg and arm, weight and vital signs. Biochemical analysis and prostatic specific antigen will be done periodically.
- Conditions
- Prostate Cancer
- Keywords
- Pedometer, Prostate, Cancer, Hormonotherapy, Exercise
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe de recherche en Urologie de la Mauricie
- Sponsor type
- University, hospital or other
- Investigators
- Dr Alain Maillette, urologist, Principal investigator, Groupe de recherche en Urologie de la Mauricie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868868
- Sponsor's protocol ID
- DC-990-0340
- Status last verified
- Mar 2009
- First submitted
- 24 Mar 2009
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedometer and Exercise Study: A Randomized Trial Evaluating the Use of a Pedometer and Brief Exercise Coaching in Prostate Cancer Patients Treated With Androgen Deprivation Therapy.
- ClinicalTrials.gov ID
- NCT00868868
- Acronym / sponsor ID
- DC-990-0340
- Conditions
- Prostate Cancer
- Keywords
- Pedometer, Prostate, Cancer, Hormonotherapy, Exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Groupe de recherche en Urologie de la MauricieUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 25 Mar 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.
A randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in prostate cancer patients treated with androgen deprivation therapy. The investigators want to demonstrate if there are less side effects of hormonal therapy and better quality of life in patients who made regular exercise.
Detailed description
To evaluate effectiveness of regular exercise and well-being all patients will complete questionnaires about sexual function (IIEF-15) and quality of life. We will also perform at each visits anthropometrics measurement of waist, leg and arm, weight and vital signs. Biochemical analysis and prostatic specific antigen will be done periodically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male subjects aged 18 years or older with histological confirmed prostate cancer.
Key inclusion criteria (5 listed)
- 18 years of age or older
- Histologically proven prostate cancer
- Treatment plan is to administer long term ADT (androgen deprivation therapy).
- Patient must currently be treated with ADT for at least 2 weeks before enrollment in trial, and for no more than 6 months. Patient treated with a maximum androgen blockade strategy, combining an anti-androgen agent with a LHRH analog agent are admissible to this protocol, but not patients treated only with an anti-androgen agent alone.
- Written informed consent to participate in the trial.
Key exclusion criteria (9 listed)
- Known hypersensitivity to Zoladex, Casodex (if applicable), or any component of these product, or to other similar agents
- Severe cardiac disease (New York Heart Association class III or greater)
- Severe lung disease
- Uncontrollable pain
- Unstable bone lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
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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.
Dr Alain Maillette, urologist principal investigator
Groupe de recherche en Urologie de la Mauricie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Groupe de recherche en Urologie de la Mauricie 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Mar 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Alain Maillette, urologist (819-373-4141, grum@cgocable.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 25 Mar 2009.