RecruitingPhase 2NCT06068543

Reducing Frailty for Older Cancer Survivors Using Supplements II

A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer

Sponsor

University of Rochester

Enrollment

118 participants

Start Date

Oct 25, 2024

Study Type

INTERVENTIONAL

Conditions

Frailty Inflammation

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

Min Age: 65 Years

Inclusion Criteria5

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 Criteria10

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)
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).