Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy

G

Groupe de recherche en Urologie de la Mauricie

Status

Unknown

Conditions

Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT00868868
DC-990-0340

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Dr Alain Maillette, urologist

Data sourced from clinicaltrials.gov

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