RECRUITING

Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial

Description

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)

Study Overview

Study Details

Study overview

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)

Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial

Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial

Condition
PROSTATE CANCER
Intervention / Treatment

-

Contacts and Locations

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02215

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Receiving chemotherapy. This study is exclusively targeting androgen deprivation therapy-related effects.
  • * Have unstable bone lesions. In general patients with severely symptomatic/unstable bone lesions due to bone metastases are at a higher risk of fractures.
  • * Complete 2 or more structured resistance exercise sessions per week over the last 4 months and participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current exercise program.
  • * Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
  • * Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting androgen deprivation therapy-related effects.
  • * Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dana-Farber Cancer Institute,

Christina Dieli-Conwright, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

2027-02-28