Recurrent Prostate CancerEASENCT02179762
Vigorous or Moderate Exercise in Enhancing Active Surveillance in Patients With Localized Prostate Cancer
A study testing moderate exercise intervention, vigorous exercise intervention - standard and questionnaire administration in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by Case Comprehensive Cancer Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer
- What is being tested?
- moderate exercise intervention, vigorous exercise intervention - standard and questionnaire administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Aug 2014to 23 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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).
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
- Being tested
- moderate exercise intervention, vigorous exercise intervention - standard, questionnaire administration, laboratory biomarker analysis, vigorous exercise intervention - cybercycling
- Keywords
- cancer survivor, prostate cancer, exercise, Active surveillance, EASE
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate exercise interventionBehavioural
Perform moderate exercise therapy
vigorous exercise intervention - standardBehavioural
Perform HIIT exercise therapy on a standard stationary bike
questionnaire administrationOther
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 analysisOther
Correlative studies
vigorous exercise intervention - cybercyclingBehavioural
perform HIIT exercise on cybercycles aided by electronic racing and other games
Exercise LogsBehavioural
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.
AdherenceBehavioural
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 testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: questionnaire administration; Other: laboratory biomarker analysis; Behavioral: vigorous exercise intervention - cybercycling; Behavioral: Exercise Logs; Behavioral: Adherence; Behavioral: Exercise and body composition test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall attendance
Average number of people who attend each session
Measured: 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
Measured: 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
Measured: Up to 16 weeks
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study start9 Aug 2014
- Primary completion23 Jul 2018
- Study completion23 Jul 2018
Why it stopped: Insufficient staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nora Nock, PhD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179762
- Sponsor's protocol ID
- CASE9814
- Other IDs
- NCI-2014-01313, CASE9814, P30CA043703
- Acronym
- EASE
- Status last verified
- Aug 2018
- First submitted
- 30 Jun 2014
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Active Surveillance With Exercise (EASE): A Pilot Randomized Trial in Localized Prostate Cancer Survivors
- ClinicalTrials.gov ID
- NCT02179762
- Acronym / sponsor ID
- EASE / CASE9814
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Aug 2014 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (moderate intensity exercise) | Experimental | Behavioral: moderate exercise intervention, Other: questionnaire administration, Other: laboratory biomarker analysis, Behavioral: Exercise Logs, Behavioral: Adherence, Behavioral: Exercise and body composition testPatients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks. |
| Arm II (HIIT exercise on a standard stationary bike) | Experimental | Behavioral: vigorous exercise intervention - standard, Other: questionnaire administration, Other: laboratory biomarker analysis, Behavioral: Exercise Logs, Behavioral: Adherence, Behavioral: Exercise and body composition testPatients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks. |
| Arm III (HIIT exercise on a cybercycle) | Experimental | Other: questionnaire administration, Other: laboratory biomarker analysis, Behavioral: vigorous exercise intervention - cybercycling, Behavioral: Exercise Logs, Behavioral: Adherence, Behavioral: Exercise and body composition testPatients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moderate exercise interventionPerform moderate exercise therapy | Behavioural | Arm I (moderate intensity exercise) |
| vigorous exercise intervention - standardPerform HIIT exercise therapy on a standard stationary bike | Behavioural | Arm II (HIIT exercise on a standard stationary bike) |
| questionnaire administrationAncillary 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 | Arm I (moderate intensity exercise), Arm II (HIIT exercise on a standard stationary bike), Arm III (HIIT exercise on a cybercycle) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (moderate intensity exercise), Arm II (HIIT exercise on a standard stationary bike), Arm III (HIIT exercise on a cybercycle) |
| vigorous exercise intervention - cybercyclingperform HIIT exercise on cybercycles aided by electronic racing and other games | Behavioural | Arm III (HIIT exercise on a cybercycle) |
| Exercise LogsThe 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. | Behavioural | Arm I (moderate intensity exercise), Arm II (HIIT exercise on a standard stationary bike), Arm III (HIIT exercise on a cybercycle) |
| AdherenceWe 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 | Behavioural | 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 testHeight 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. | Behavioural | Arm I (moderate intensity exercise), Arm II (HIIT exercise on a standard stationary bike), Arm III (HIIT exercise on a cybercycle) |
Primary outcome
Overall attendance
Time frame: 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
Time frame: 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
Time frame: 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
17 secondary outcomes
Average change in the Exercise Motivations Inventory (EMI-2)
Time frame: Baseline up to 16 weeks
Change in quality of life, measured using the Functional Assessment of Cancer Therapy (FACT)
Time frame: Baseline up to 16 weeks
Average change in fitness
Time frame: Baseline up to 16 weeks
Change in body mass index as a measure of body composition
Time frame: Baseline up to 16 weeks
Change in cognition
Time frame: Baseline up to 16 weeks
Change in eating behaviors
Time frame: Baseline up to 16 weeks
Change in leptin
Time frame: Baseline up to 16 weeks
Change in insulin
Time frame: Baseline up to 16 weeks
Change in adiponectin
Time frame: Baseline up to 16 weeks
Change in resistin
Time frame: Baseline up to 16 weeks
Change in IGF-1
Time frame: Baseline up to 16 weeks
Change in IGFBP-1
Time frame: Baseline up to 16 weeks
Change in IGFBP-3
Time frame: Baseline up to 16 weeks
Change in TNF-alpha
Time frame: Baseline up to 16 weeks
Average change in the Exercise Causality Orientations Scale (ECOS)
Time frame: Baseline up to 16 weeks
Change in waist/hip circumference ratio as a measure of body composition
Time frame: Baseline up to 16 weeks
Change in total body fat as a measure of body composition
Time frame: Baseline up to 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Nock, PhD principal investigator
Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing moderate exercise intervention, vigorous exercise intervention - standard and questionnaire administration in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by Case Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall attendance (time frame: Up to 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.