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

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02179762

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arms

47.4

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer	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	N/A

Detailed Description

PRIMARY OBJECTIVES:

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).
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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 9, 2014

Actual Primary Completion Date :

Jul 23, 2018

Actual Study Completion Date :

Jul 23, 2018

Arms and Interventions

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.	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) Other: laboratory biomarker analysis Correlative studies 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.	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: 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 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: 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.

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.

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)

Other: laboratory biomarker analysis

Correlative studies

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.

Behavioral: vigorous exercise intervention - standard

Perform HIIT exercise therapy on a standard stationary bike

Other: questionnaire administration

Other: laboratory biomarker analysis

Correlative studies

Behavioral: Exercise Logs

Behavioral: Adherence

Behavioral: Exercise and body composition test

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: questionnaire administration

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

Behavioral: Adherence

Behavioral: Exercise and body composition test

Outcome Measures

Primary Outcome Measures

Overall attendance [Up to 16 weeks]
Average number of people who attend each session
Overall adherence to the exercise protocol as measured by average time in HIIT intervals for HIIT groups [Up to 16 weeks]
Average number of minutes in HIIT intervals which are defined as exercising at 80-90% WR_peak
Adherence to the exercise protocol as measured by average time in the target heart rate (THR) zone [Up to 16 weeks]
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

Secondary Outcome Measures

Average change in the Exercise Motivations Inventory (EMI-2) [Baseline up to 16 weeks]
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.
Change in quality of life, measured using the Functional Assessment of Cancer Therapy (FACT) [Baseline up to 16 weeks]
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.
Average change in fitness [Baseline up to 16 weeks]
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.
Change in body mass index as a measure of body composition [Baseline up to 16 weeks]
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.
Change in cognition [Baseline up to 16 weeks]
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.
Change in eating behaviors [Baseline up to 16 weeks]
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.
Change in leptin [Baseline up to 16 weeks]
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in insulin [Baseline up to 16 weeks]
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in adiponectin [Baseline up to 16 weeks]
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in resistin [Baseline up to 16 weeks]
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in IGF-1 [Baseline up to 16 weeks]
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in IGFBP-1 [Baseline up to 16 weeks]
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in IGFBP-3 [Baseline up to 16 weeks]
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Change in TNF-alpha [Baseline up to 16 weeks]
Paired t-tests will be used to evaluate changes as well as mixed linear models adjusted for potential confounding factors.
Average change in the Exercise Causality Orientations Scale (ECOS) [Baseline up to 16 weeks]
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.
Change in waist/hip circumference ratio as a measure of body composition [Baseline up to 16 weeks]
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.
Change in total body fat as a measure of body composition [Baseline up to 16 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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