Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE 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 supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT). The names of the study intervention involved in this study is: • Supervised circuit training (aerobic and resistance exercise regimen)

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

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

• Diagnosed with metastatic prostate cancer.

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

• Have been receiving androgen deprivation (either with or without androgen receptor targeted treatment) for at least one month and expect to remain on their treatment for at least 4 months.

• Are pre-frail or frail as indicated by the FRAIL scale (a score of 1-2 = pre-frail; 3-5 = frail).

• Have physician's clearance to participate in exercise.

• Speak English.

• Participate in less than 2 structured resistance exercise sessions per week over the last 4 months.

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

• Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Dana-Farber Cancer Institute
NOT_YET_RECRUITING
Boston
Contact Information
Primary
Christina Dieli-Conwright, MD
ChristinaM_Dieli-Conwright@dfci.harvard.edu
617-582-8321
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 80
Treatments
Experimental: Exercise Group
Participants will partake in a 16-week supervised exercise program.
Experimental: Attention Control Group
Participants will continue with their normal daily activities.
Related Therapeutic Areas
Sponsors
Collaborators: Prostate Cancer Foundation
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov