Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer
| Status: | Suspended |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 7/13/2016 |
| Start Date: | August 2014 |
| End Date: | June 2017 |
Enhancing Active Surveillance With Exercise (EASE): A Pilot Randomized Trial in Localized Prostate Cancer Survivors
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.
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.
PRIMARY OBJECTIVES:
I. To determine the feasibility of performing vigorous intensity aerobic exercise using
progressive, high-intensity interval training (HIIT) with standard stationary cycling and
'cybercycling' compared to moderate intensity aerobic exercise with standard stationary
cycling in prostate cancer (PCa) survivors on active surveillance (AS).
II. To explore the potential effects of vigorous intensity aerobic exercise (HIIT) using
standard cycling and 'cybercycling' compared to moderate intensity standard cycling on
changes in quality of life (QoL), cognition, fitness circulating inflammatory biomarkers and
PCa-specific markers of progression (prostate specific antigen [PSA], time to AT) in PCa
survivors in active surveillance (AS); and, to explore if these effects may be mediated by
changes in body fat.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes,
three days a week for 16 weeks.
ARM II: Patients perform HIIT exercise on a standard stationary bike, three days a week for
16 weeks.
ARM III: Patients perform HIIT exercise on a cybercycle using racing or other games, three
days a week for 16 weeks.
After completion of study, patients are followed up at 6 and 12 months.
I. To determine the feasibility of performing vigorous intensity aerobic exercise using
progressive, high-intensity interval training (HIIT) with standard stationary cycling and
'cybercycling' compared to moderate intensity aerobic exercise with standard stationary
cycling in prostate cancer (PCa) survivors on active surveillance (AS).
II. To explore the potential effects of vigorous intensity aerobic exercise (HIIT) using
standard cycling and 'cybercycling' compared to moderate intensity standard cycling on
changes in quality of life (QoL), cognition, fitness circulating inflammatory biomarkers and
PCa-specific markers of progression (prostate specific antigen [PSA], time to AT) in PCa
survivors in active surveillance (AS); and, to explore if these effects may be mediated by
changes in body fat.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes,
three days a week for 16 weeks.
ARM II: Patients perform HIIT exercise on a standard stationary bike, three days a week for
16 weeks.
ARM III: Patients perform HIIT exercise on a cybercycle using racing or other games, three
days a week for 16 weeks.
After completion of study, patients are followed up at 6 and 12 months.
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
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
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