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Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Groupe de recherche en Urologie de la Mauricie.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00868868
First Posted: March 25, 2009
Last Update Posted: March 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Groupe de recherche en Urologie de la Mauricie
  Purpose
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
Prostate Cancer

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Groupe de recherche en Urologie de la Mauricie:

Estimated Enrollment: 400
Study Start Date: June 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male subjects aged 18 years or older with histological confirmed prostate cancer.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868868


Contacts
Contact: Dr Alain Maillette, urologist 819-373-4141 grum@cgocable.ca

Locations
Canada
Groupe de Recherche en Urologie de la Mauricie Recruiting
Trois-Rivières, Canada, G9A 3V7
Contact: Dr Alain Maillette, Urologist    819-373-4141    grum@cgocable.ca   
Principal Investigator: Dr Alain Maillette, Urologist         
Sponsors and Collaborators
Groupe de recherche en Urologie de la Mauricie
Investigators
Principal Investigator: Dr Alain Maillette, urologist Groupe de recherche en Urologie de la Mauricie
  More Information

Responsible Party: Dr Alain Maillette, Groupe de Recherche en Urologie de la Mauricie
ClinicalTrials.gov Identifier: NCT00868868     History of Changes
Other Study ID Numbers: DC-990-0340
First Submitted: March 24, 2009
First Posted: March 25, 2009
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Groupe de recherche en Urologie de la Mauricie:
Pedometer
Prostate
Cancer
Hormonotherapy
Exercise

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases