Clinical trial NCT02179762: Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer
Official title: Enhancing Active Surveillance With Exercise (EASE): A Pilot Randomized Trial in Localized Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Keywords: cancer survivor
prostate cancer
exercise
Active surveillance
EASE
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-02
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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
* Patients not available for follow-up tests
* Patients with pre-existing medical conditions that would be a barrier to exercise

Primary outcomes:
measure: Overall attendance
timeFrame: Up to 16 weeks
measure: Overall adherence to the exercise protocol as measured by average time in HIIT intervals for HIIT groups
timeFrame: Up to 16 weeks
measure: Adherence to the exercise protocol as measured by average time in the target heart rate (THR) zone
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Average change in the Exercise Motivations Inventory (EMI-2)
timeFrame: Baseline up to 16 weeks
measure: Change in quality of life, measured using the Functional Assessment of Cancer Therapy (FACT)
timeFrame: Baseline up to 16 weeks
measure: Average change in fitness
timeFrame: Baseline up to 16 weeks
measure: Change in body mass index as a measure of body composition
timeFrame: Baseline up to 16 weeks
measure: Change in cognition
timeFrame: Baseline up to 16 weeks
measure: Change in eating behaviors
timeFrame: Baseline up to 16 weeks
measure: Change in leptin
timeFrame: Baseline up to 16 weeks
measure: Change in insulin
timeFrame: Baseline up to 16 weeks
measure: Change in adiponectin
timeFrame: Baseline up to 16 weeks
measure: Change in resistin
timeFrame: Baseline up to 16 weeks
measure: Change in IGF-1
timeFrame: Baseline up to 16 weeks
measure: Change in IGFBP-1
timeFrame: Baseline up to 16 weeks
measure: Change in IGFBP-3
timeFrame: Baseline up to 16 weeks
measure: Change in TNF-alpha
timeFrame: Baseline up to 16 weeks
measure: Average change in the Exercise Causality Orientations Scale (ECOS)
timeFrame: Baseline up to 16 weeks
measure: Change in waist/hip circumference ratio as a measure of body composition
timeFrame: Baseline up to 16 weeks
measure: Change in total body fat as a measure of body composition
timeFrame: Baseline up to 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Nora Nock, PhD
role: PRINCIPAL_INVESTIGATOR
References: