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

Recurrent Prostate Cancer Clinical Trial

— EASE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02179762
• Other study ID #: CASE9814
• Secondary ID: NCI-2014-01313CA
• Status: Withdrawn
• Phase: N/A
• Start date: August 9, 2014
• Est. completion date: July 23, 2018

Study information

• Verified date: August 2018
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 23, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• moderate exercise intervention
Perform moderate exercise therapy
• 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)
• laboratory biomarker analysis
Correlative studies

Behavioral:
• vigorous exercise intervention - cybercycling
perform HIIT exercise on cybercycles aided by electronic racing and other games
• 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.
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall attendance	Average number of people who attend each session	Up to 16 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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