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

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

Inclusion 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.

Exclusion Criteria:

* 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.

Conditions4

Locations3 sites

Browse More Trials