Status:
RECRUITING
Reducing Frailty for Older Cancer Survivors Using Supplements II
Lead Sponsor:
University of Rochester
Conditions:
Frailty
Inflammation
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.
Eligibility Criteria
Inclusion
- Be age 65 or over.
- Be diagnosed with stage I-III Cancer
- Have completed curative intent treatment ≤10 years prior to screening Patients on the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
- Have a Fried's Frailty Score (FFS) of ≥ 1
- Able to provide informed consent
Exclusion
- Have chemotherapy or other systemic cancer treatment planned to occur during the study period.
- Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening)
- 3 times institutional upper limit of normal for ALT and AST
- 5 times institutional upper limit of normal for bilirubin
- Have uncontrolled or unmanaged liver disease.
- Consume more than 6 cups of green tea per day.
- Have known allergies to caffeine.
- Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
- Be diagnosed with dementia.
- Cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist).
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06068543
Start Date
September 30 2024
End Date
December 31 2030
Last Update
January 29 2025
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14627