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

NCT02179762 | Withdrawn

• 3 other identifiers: CASE9814NCI-2014-01313P30CA043703
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Average change in the Exercise Motivations Inventory (EMI-2)

  Baseline up to 16 weeks

• Change in quality of life, measured using the Functional Assessment of Cancer Therapy (FACT)

  Baseline up to 16 weeks

• Average change in fitness

  Baseline up to 16 weeks

• Change in body mass index as a measure of body composition

  Baseline up to 16 weeks

• Change in cognition

  Baseline up to 16 weeks

Study Arms (3)

Arm I (moderate intensity exercise)

EXPERIMENTAL

Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.

Behavioral: moderate exercise intervention; Other: questionnaire administration; Other: laboratory biomarker analysis; Behavioral: Exercise Logs; Behavioral: Adherence; Behavioral: Exercise and body composition test

Arm II (HIIT exercise on a standard stationary bike)

EXPERIMENTAL

Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.

Behavioral: vigorous exercise intervention - standard; Other: questionnaire administration; Other: laboratory biomarker analysis; Behavioral: Exercise Logs; Behavioral: Adherence; Behavioral: Exercise and body composition test

Arm III (HIIT exercise on a cybercycle)

EXPERIMENTAL

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; Behavioral: vigorous exercise intervention - cybercycling; Behavioral: Exercise Logs; Behavioral: Adherence; Behavioral: Exercise and body composition test

Interventions

moderate exercise intervention BEHAVIORAL

Perform moderate exercise therapy

Arm I (moderate intensity exercise)

vigorous exercise intervention - standard BEHAVIORAL

Perform HIIT exercise therapy on a standard stationary bike

Arm II (HIIT exercise on a standard stationary bike)

questionnaire administration OTHER

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)

Arm I (moderate intensity exercise); Arm II (HIIT exercise on a standard stationary bike); Arm III (HIIT exercise on a cybercycle)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (moderate intensity exercise); Arm II (HIIT exercise on a standard stationary bike); Arm III (HIIT exercise on a cybercycle)

vigorous exercise intervention - cybercycling BEHAVIORAL

perform HIIT exercise on cybercycles aided by electronic racing and other games

Arm III (HIIT exercise on a cybercycle)

Exercise Logs BEHAVIORAL

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.

Arm I (moderate intensity exercise); Arm II (HIIT exercise on a standard stationary bike); Arm III (HIIT exercise on a cybercycle)

Adherence BEHAVIORAL

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

Arm I (moderate intensity exercise); Arm II (HIIT exercise on a standard stationary bike); Arm III (HIIT exercise on a cybercycle)

Exercise and body composition test BEHAVIORAL

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 I (moderate intensity exercise); Arm II (HIIT exercise on a standard stationary bike); Arm III (HIIT exercise on a cybercycle)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nora Nock, PhD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: August 9, 2014
• Primary Completion: July 23, 2018
• Study Completion: July 23, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08