Recruiting

Exercise

Sponsor:

Groupe de recherche en Urologie de la Mauricie

Code:

NCT00868868

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT00868868

Start date

Jun, 2008

Status verified date

Mar, 2009

Completion date

Sep, 2011

Anticipated

Primary completion date

Sep, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Dr Alain Maillette, urologist

819-373-4141grum@cgocable.ca

Locations

Groupe de Recherche en Urologie de la Mauricie

Recruiting

Trois-Rivières, Canada, G9A 3V7

Contacts

Dr Alain Maillette, Urologist

819-373-4141grum@cgocable.ca

Principal Investigator:

Dr Alain Maillette, Urologist

More Information

Sponsor

Groupe de recherche en Urologie de la Mauricie

Last update posted

Mar 25, 2009

Last verified

Mar, 2009

Keywords

  • Pedometer
  • Prostate
  • Cancer
  • Hormonotherapy
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Groupe de recherche en Urologie de la Mauricie on 2009-03-25.