Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
Recruiting now · Not applicable
Conditions studied: PROSTATE CANCER, Metastatic Prostate Cancer, Metastatic Prostate Carcinoma
In brief
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)
Key facts
- Study ID
- NCT06040125
- Run by
- Dana-Farber Cancer Institute
- People needed
- 80
- Starts
- 2024-01-01
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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