Design of debunking the frailty-sarcopenia-ADT axis in metastatic prostate cancer with multicomponent exercise: the FIERCE trial protocol.
Rebekah L Wilson, Anderson Vulczak, Alicia K Morgans...
https://pubmed.ncbi.nlm.nih.gov/41210271/Actively Recruiting
Led by Dana-Farber Cancer Institute · Updated on 2026-03-11
80
Participants Needed
3
Research Sites
26 weeks
Total Duration
Researchers are evaluating whether a 16-week supervised exercise program combining resistance and aerobic exercises can improve frailty, muscle loss sarcopenia, and disease outcomes in men with metastatic prostate cancer who are receiving androgen deprivation therapy. This pilot randomized controlled study is the first to test this intervention in this patient group. The study is funded by the Prostate Cancer Foundation and led by Dana-Farber Cancer Institute. Participants are randomly assigned to either a supervised circuit training group or an attention control group. The exercise group will complete a 16-week multicomponent program with sessions supervised by a certified exercise oncology trainer and home-based aerobic exercises. They will use a stationary bike and wear an activity and heart rate monitor. The control group will continue their normal daily activities without additional exercise intervention. During the study, participants will undergo screening and extensive evaluations including fitness and strength tests, blood tests, muscle biopsies, and surveys. Researchers will assess changes in inflammation and frailty from baseline to after the 16-week program, along with muscle loss and muscle biomarkers. Participants will be monitored for safety and adherence throughout. Total participation is expected to last about 16 weeks.
CONDITIONS
Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
C
Christina Dieli-Conwright, MD
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Dana-Farber Cancer Institute
Lead Sponsor
Prostate Cancer Foundation
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Supervised Multicomponent Exercise | Attention Control (Current Activity and Support) |
|---|---|---|
| What it is | A 16-week supervised program combining circuit training with home-based aerobic exercise for men with metastatic prostate cancer on androgen deprivation therapy. | Participants continue their current physical activity and receive educational support, but do not start a new exercise regimen. |
| Role in trial | Evaluates the effects of a structured exercise intervention on inflammation, frailty, and muscle health. | Provides a comparison baseline by maintaining participants’ everyday activity and education level without new exercise. |
| Primary use | Test whether a multicomponent exercise program can impact frailty, inflammation, and muscle loss (sarcopenia) in this patient population. | Observe outcomes in patients continuing current lifestyle and receiving information support, reflecting what typically occurs outside a structured program. |
| How it is given or performed | Certified exercise oncology trainers supervise group circuit sessions, with participants also completing home-based aerobic exercises. Activity is monitored via provided devices. | Participants receive educational materials about exercise and well-being but are not assigned structured exercise sessions. |
| Evidence status | Efficacy and impact on frailty, inflammation, and muscle health are under investigation. No published outcome data are available yet. | Represents usual practice for similar patients outside structured exercise programs. No new intervention is studied. |
| Important limitations | Results are not yet available, and safety for all subgroups (e.g., those with unstable bone lesions or significant comorbidities) remains to be established. The intervention is restricted to participants who can safely perform unsupervised and supervised exercise. | Provides a comparison to baseline activity but does not assess the impact of structured exercise versus other possible interventions. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants in the Exercise Group engage in a 16-week supervised multicomponent exercise program, including sessions with a certified exercise trainer and home-based aerobic exercises. Participants in the Attention Control Group continue their normal daily activities without the supervised exercise intervention.
Multiple supervised and home-based exercise sessions over 16 weeks
Duration - 1 week
Participants complete evaluations of fitness, physical health and strength, blood tests, muscle biopsy, and surveys at baseline and post-intervention to assess changes.
2 visits (baseline and post-intervention assessments)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Rebekah L Wilson, Anderson Vulczak, Alicia K Morgans...
https://pubmed.ncbi.nlm.nih.gov/41210271/Dana-Farber Cancer Institute
Lead Sponsor
Prostate Cancer Foundation
Collaborating Sponsor