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Behavioral Intervention
Exercise for Prostate Cancer
N/A
Recruiting
Led By Dong-Woo Kang, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 1) and post-intervention (week 18)
Awards & highlights
Study Summary
This trial will assess if exercise can slow prostate cancer progression in Black men on active surveillance.
Who is the study for?
This trial is for Black men over 18 with early-stage prostate cancer who are on active surveillance. They should be able to visit Dana-Farber Cancer Institute, understand English, sign consent forms, and have medical clearance to exercise. They must do less than 60 minutes of moderate-to-vigorous exercise weekly and not plan any invasive treatments for the next 16 weeks.Check my eligibility
What is being tested?
The REMOVE Trial tests if a home-based, virtual high-intensity interval training (HIIT) program can slow prostate cancer progression in participants. It's a supervised 16-week aerobic exercise regimen designed specifically for this study.See study design
What are the potential side effects?
While specific side effects aren't listed for this type of non-drug intervention, general risks may include muscle soreness, fatigue or injury from physical activity. Participants will be monitored for any adverse reactions related to the exercise program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 1) and post-intervention (week 18)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 1) and post-intervention (week 18)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate-Specific Antigen (PSA) Level
Secondary outcome measures
Cardiorespiratory Fitness
Fear of Cancer Progression Assessment
Health-Related Quality of Life
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group B: 16-Week Usual CareExperimental Treatment1 Intervention
Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows:
Testing visits at Week 1 and 18 for physical exams, physical fitness and function assessments, and survey questionnaires.
Upon completion of post-intervention assessments, participants will have the option to take part in the 16-week HIIT exercise program.
Group II: Group A: 16-Week HIIT Exercise ProgramExperimental Treatment1 Intervention
Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows:
Testing visits at Week 1, 9, and 19 for physical exams, physical fitness and function assessments, survey questionnaires, and cardiopulmonary fitness assessment.
Virtual, aerobic training sessions three times weekly with trained oncology exercise specialist.
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,912 Total Patients Enrolled
76 Trials studying Prostate Cancer
16,037 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,712 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,862 Patients Enrolled for Prostate Cancer
Dong-Woo Kang, PhDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
40 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer that has spread or I am being treated for another cancer.I am currently being closely monitored for my condition without active treatment.I do not plan to undergo invasive prostate cancer treatment within the next 16 weeks.I have been diagnosed with early-stage prostate cancer.My urologist has approved me for exercise and testing.I am currently undergoing treatment aimed at curing my prostate cancer.I am 18 years old or older.I don't have health issues that worsen with exercise.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: 16-Week HIIT Exercise Program
- Group 2: Group B: 16-Week Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research accepting applications for participants?
"Clinicaltrials.gov records state this medical trial is no longer welcoming candidates, as it was originally posted on December 1st 2023 and last updated June 23rd of the same year. However, 1325 other studies are still recruiting participants at present."
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