Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
| 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) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Male subjects aged 18 years or older with histological confirmed prostate cancer.
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| Contact: Dr Alain Maillette, urologist | 819-373-4141 | grum@cgocable.ca |
| 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 | |
| Principal Investigator: | Dr Alain Maillette, urologist | Groupe de recherche en Urologie de la Mauricie |
More Information
No publications provided
| 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 |
| Study First Received: | March 24, 2009 |
| Last Updated: | March 24, 2009 |
| Health Authority: | Canada: Health Canada |
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 |
ClinicalTrials.gov processed this record on May 23, 2013