Exercise for Tumor Suppressive Impact in Black Men With Prostate Cancer on Active Surveillance: The REMOVE Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to determine whether a 16-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among Black men with prostate cancer undergoing active surveillance. The name of the study intervention involved in this study is: Aerobic high-intensity interval training (HIIT) (training exercise intervention)

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years; due to the rarity of the disease in those \<18 years, this age bracket will not be included

• Self-identify as Black

• Diagnosed with early-stage (e.g., very-low to favorable-intermediate grade), localized prostate cancer

• Initiating or having been undergoing active surveillance

• No plans for invasive treatment for their prostate cancer in the following 16 weeks from the time of enrollment

• Medical clearance to perform exercise intervention and testing by their treating urologist

• No uncontrolled medical conditions that could be exacerbated with exercise

• Ability to communicate and complete written forms in English

• Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month

• Ability to understand and the willingness to sign informed consent prior to any study-related procedures

• Willing to travel to Dana-Farber Cancer Institute for necessary data collection

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Christina Dieli-Conwright, PhD, MPH
ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU
617-582-8321
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 68
Treatments
Experimental: Group A: 16-Week HIIT Exercise Program
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.
Experimental: Group B: 16-Week Usual Care
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.
Related Therapeutic Areas
Sponsors
Collaborators: Prostate Cancer Foundation
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov