Clinical Trial Details

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Study ID CASE9814
Investigator
Nora Nock,   Case Comprehensive Cancer Center
Title Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer
Conditions Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Interventions Behavioral: moderate exercise intervention
Behavioral: vigorous exercise intervention - standard
Other: questionnaire administration
Other: laboratory biomarker analysis
Behavioral: vigorous exercise intervention - cybercycling
Behavioral: Exercise Logs
Behavioral: Adherence
Behavioral: Exercise and body composition test
Phase N/A
Purpose This randomized pilot clinical trial compares vigorous or moderate exercise in enhancing active surveillance in patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Active surveillance involves watching the patient's condition but not giving any treatment unless test results show that the patient's condition is getting worse. Exercise may improve fitness, quality of life, brain health, and blood biomarkers in patients with prostate cancer on active surveillance. It is not yet known whether vigorous or moderate exercise works better in enhancing active surveillance in patients with localized prostate cancer.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Adult men of all races and body size with histologically confirmed localized PCa on AS
  • Approved to be contacted by the treating urologist
  • Meet screening criteria - Complete American Heart Association (AHA)/American College of Sports Medicine (ACSM) exercise questionnaire - Undergo cardiopulmonary exercise (CPX) testing utilizing a cycle ergometer. If the CPX test is terminated secondary to hemodynamic instability, arrhythmias or ischemic signs, the patient will be ineligible.
Exclusion Criteria:
  • Patients unable to provide informed consent
  • Patients participating in a structured exercise program in the past 6 months (mos)
  • Patients not available for follow-up tests
  • Patients with pre-existing medical conditions that would be a barrier to exercise
Study Location
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Contact Nora Nock
216-368-5653
nln@case.edu
Information objtained from ClinicalTrials.gov, on 7/31/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02179762


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