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

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.

Study Overview

• Status: Withdrawn
• Conditions: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Behavioral: moderate exercise intervention; Other: questionnaire administration; Behavioral: Exercise Logs; Behavioral: Adherence; Behavioral: Exercise and body composition test; Behavioral: vigorous exercise intervention - standard; Behavioral: vigorous exercise intervention - cybercycling

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (moderate intensity exercise); Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.	Other: laboratory biomarker analysis; Correlative studies; Behavioral: moderate exercise intervention; Perform moderate exercise therapy; 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); 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.
Experimental: Arm II (HIIT exercise on a standard stationary bike); Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.	Other: laboratory biomarker analysis; Correlative studies; 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); 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.; Behavioral: vigorous exercise intervention - standard; Perform HIIT exercise therapy on a standard stationary bike
Experimental: Arm III (HIIT exercise on a cybercycle); Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.	Other: laboratory biomarker analysis; Correlative studies; 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); 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.; Behavioral: vigorous exercise intervention - cybercycling; perform HIIT exercise on cybercycles aided by electronic racing and other games

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall attendance	Average number of people who attend each session	Up to 16 weeks
Overall adherence to the exercise protocol as measured by average time in HIIT intervals for HIIT groups	Average number of minutes in HIIT intervals which are defined as exercising at 80-90% WR_peak	Up to 16 weeks
Adherence to the exercise protocol as measured by average time in the target heart rate (THR) zone	the target heart rate zone will be determined using the Karvonen formula: THR=((HRmax - HRrest) × % Intensity) + HRrest. Total time in this zone will be recorded every 5 minutes and the overall average will be recorded	Up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change in the Exercise Motivations Inventory (EMI-2)	The EMI-2 is a validated, 51 item instrument where each question is scored 0-5 and higher scores indicate greater motivation. Average changes will be analyzed using t-tests as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in quality of life, measured using the Functional Assessment of Cancer Therapy (FACT)	A 25 item scale scored 0-4 where lower indicate greater quality of life. Paired t-tests will be used to evaluate change as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Average change in fitness	Difference in VO2 maximum 30 second intake from beginning of study to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in body mass index as a measure of body composition	Change in body mass index (function of height and weight) from baseline to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in cognition	Average change in score of cognitive survey. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in eating behaviors	61 items where higher scores indicate healthier eating behaviors. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in leptin	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in insulin	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in adiponectin	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in resistin	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in IGF-1	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in IGFBP-1	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in IGFBP-3	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in TNF-alpha	Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Average change in the Exercise Causality Orientations Scale (ECOS)	The ECOS is a validated, 21 item instrument where each question is scored 1-7 and higher scores indicate greater motivation. Average changes will be analyzed using t-tests as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in waist/hip circumference ratio as a measure of body composition	Change in waist and hip circumference ratio from baseline to end of treatment. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks
Change in total body fat as a measure of body composition	Change in total body fat from baseline to end of treatment as measured by whole body dual-energy X-ray absorptiometry scans. Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.	Baseline up to 16 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Nora Nock, PhD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2014
• Primary Completion (Actual): July 23, 2018
• Study Completion (Actual): July 23, 2018

Study Registration Dates

• First Submitted: June 30, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: exercise; prostate cancer; cancer survivor; Active surveillance; EASE
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CASE9814 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-01313 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No