Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy

Sponsor

Groupe de recherche en Urologie de la Mauricie (Other)

Overall Status

Unknown status

CT.gov ID

NCT00868868

Collaborator

(none)

400

Enrollment

Location

Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer

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

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Study Start Date :

Jun 1, 2008

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.