NCT02179762

Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer

Enhancing Active Surveillance With Exercise (EASE): A Pilot Randomized Trial in Localized Prostate Cancer Survivors

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	moderate exercise intervention	Perform moderate exercise therapy
BEHAVIORAL	vigorous exercise intervention - standard	Perform HIIT exercise therapy on a standard stationary bike
OTHER	questionnaire administration	Ancillary studies: Functional Assessment of Cancer Therapy-General (FACT-G), Godin Leisure-Time Exercise questionnaire, 24-hour diet recalls, USDA 5 Step Multiple Pass Method, Memorial Anxiety Scale for Prostate Cancer, Pittsburgh Sleep Quality Index (PSQI)
OTHER	laboratory biomarker analysis	Correlative studies
BEHAVIORAL	vigorous exercise intervention - cybercycling	perform HIIT exercise on cybercycles aided by electronic racing and other games
BEHAVIORAL	Exercise Logs	The exercise physiologists will keep exercise logs and tracking sheets that log the date, start and stop time (duration) of exercise sessions as well as time in the THR and RPE for each exercise session.
BEHAVIORAL	Adherence	We will assess barriers to adhering to the exercise protocol by asking an open-ended question to solicit barriers. If the patient calls to cancel an exercise session, he will be called and probed for reasons
BEHAVIORAL	Exercise and body composition test	Height will be measured to the nearest 0.1 cm and weight will be measured to the nearest 0.1 kg. Waist and hip circumference will be measured to the nearest 1/8 inch. Whole body dual-energy X-ray absorptiometry scans will be conducted at baseline and end of treatment to quantify total body fat.

Timeline

• Start date: 2014-08-09
• Primary completion: 2018-07-23
• Completion: 2018-07-23
• First posted: 2014-07-02
• Last updated: 2018-08-09