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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.


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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.


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Dr Alain Maillette, urologist

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe de recherche en Urologie de la Mauricie

Authority:

Canada: Health Canada

Study ID:

DC-990-0340

NCT ID:

NCT00868868

Start Date:

June 2008

Completion Date:

September 2011

Related Keywords:

  • Prostate Cancer
  • Pedometer
  • Prostate
  • Cancer
  • Hormonotherapy
  • Exercise
  • Prostatic Neoplasms

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