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Behavioral Intervention
Exercise Program for Prostate Cancer
N/A
Recruiting
Led By Christina Dieli-Conwright, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) and post-intervention (week 17)
Awards & highlights
Study Summary
This trial is to find if it can help prostate cancer patients improve their frailty and sarcopenic status through a 16-week exercise program.
Who is the study for?
The FIERCE Trial is for English-speaking men over 18 with metastatic prostate cancer who are pre-frail or frail and on ADT. They must be willing to travel to Dana-Farber Cancer Institute, have physician clearance for exercise, and not already doing much structured exercise.Check my eligibility
What is being tested?
This study tests a 16-week supervised circuit training program combining resistance and functional exercises with self-directed aerobic activity. It aims to see if this can improve frailty, sarcopenia (muscle loss), and disease progression in patients.See study design
What are the potential side effects?
While the trial itself doesn't involve medication that would cause side effects, exercising may lead to muscle soreness, fatigue, or injury especially if participants are not used to physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with prostate cancer that has spread.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 0) and post-intervention (week 17)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) and post-intervention (week 17)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Circulating Inflammation for Exercise Group
Frailty
Secondary outcome measures
Sarcopenia
Skeletal Muscle Biomarkers - myokines
Trial Design
2Treatment groups
Experimental Treatment
Group I: Exercise GroupExperimental Treatment1 Intervention
Participants will partake in a 16-week supervised exercise program.
Group II: Attention Control GroupExperimental Treatment1 Intervention
Participants will continue with their normal daily activities.
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,900 Total Patients Enrolled
77 Trials studying Prostate Cancer
16,105 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,700 Total Patients Enrolled
28 Trials studying Prostate Cancer
1,930 Patients Enrolled for Prostate Cancer
Christina Dieli-Conwright, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
30 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for patients in this medical experiment?
"Unfortunately, this clinical trial is not currently accepting new participants. Initially posted on November 1st 2023 and last edited on September 13th 2023, it has stopped recruiting for the time being. Nevertheless, there are over 1500 other medical studies that are still actively seeking patients."
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