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Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy

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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00868868
Enrollment
400
Registered
2009-03-25
Start date
2008-06-30
Completion date
2011-09-30
Last updated
2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Pedometer, Prostate, Cancer, Hormonotherapy, Exercise

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 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.

Interventions

None listed

Sponsors

Groupe de recherche en Urologie de la Mauricie
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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 criteria

* 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.

Countries

Canada

Contacts

Primary ContactDr Alain Maillette, urologist
grum@cgocable.ca819-373-4141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026