Status:
UNKNOWN
Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy
Lead Sponsor:
Groupe de recherche en Urologie de la Mauricie
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief 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 i...
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 anthropo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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, ...)
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00868868
Start Date
June 1 2008
End Date
September 1 2011
Last Update
March 25 2009
Active Locations (1)
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1
Groupe de Recherche en Urologie de la Mauricie
Trois-Rivières, Canada, G9A 3V7