RecruitingNot ApplicableNCT06040125

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

Sponsor

Dana-Farber Cancer Institute

Enrollment

80 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Metastatic Prostate Carcinoma Metastatic Prostate Cancer

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria10

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 Criteria6

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.

Interventions

BEHAVIORALSupervised Circuit Training

16-week, multicomponent exercise intervention comprised of sessions supervised by certified exercise oncology trainer and home-based, self-directed aerobic exercises. Stationary bike and accelerometer (activity/heart rate monitor) will be provided.