Clinical trial NCT00868868: Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Pedometer
Prostate
Cancer
Hormonotherapy
Exercise
Lead sponsor: Groupe de recherche en Urologie de la Mauricie
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male subjects aged 18 years or older with histological confirmed prostate cancer.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Groupe de Recherche en Urologie de la Mauricie
Study officials:
affiliation: Groupe de recherche en Urologie de la Mauricie
name: Dr Alain Maillette, urologist
role: PRINCIPAL_INVESTIGATOR
References: