RECRUITING

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

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Conditions

PROSTATE CANCERMetastatic Prostate CancerMetastatic Prostate Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2024-01-01
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06040125

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to understand and the willingness to sign informed consent prior to any study-related procedures.
  2. * Diagnosed with metastatic prostate cancer.
  3. * Aged ≥18 years; due to the rarity of the disease in those \<18 years, this age bracket will not be included.
  4. * 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.
  5. * Are pre-frail or frail as indicated by the FRAIL scale (a score of 1-2 = pre-frail; 3-5 = frail).
  6. * Have physician's clearance to participate in exercise.
  7. * Speak English.
  8. * Participate in less than 2 structured resistance exercise sessions per week over the last 4 months.
  9. * Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month.
  10. * Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.
  1. * Receiving chemotherapy. This study is exclusively targeting androgen deprivation therapy-related effects.
  2. * Have unstable bone lesions. In general patients with severely symptomatic/unstable bone lesions due to bone metastases are at a higher risk of fractures.
  3. * 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.
  4. * 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.
  5. * Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting androgen deprivation therapy-related effects.
  6. * Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.

Contacts and Locations

Study Contact

Christina Dieli-Conwright, MD
CONTACT
617-582-8321
ChristinaM_Dieli-Conwright@dfci.harvard.edu

Principal Investigator

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

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer
  • Metastatic Prostate Cancer
  • Metastatic Prostate Carcinoma

Additional Relevant MeSH Terms

  • PROSTATE CANCER
  • Metastatic Prostate Cancer
  • Metastatic Prostate Carcinoma