A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
University of Rochester
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
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Be age 65 or over. 2. Be diagnosed with stage I-III Cancer 3. 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) 4. Have a Fried's Frailty Score (FFS) of ≥ 1 5. Able to provide informed consent Exclusion Criteria: 1. Have chemotherapy or other systemic cancer treatment planned to occur during the study period. 2. Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of scree…
Interventions
- DrugEpigallocatechin-3-Gallate (EGCG)
800mg Epigallocatechin-3-Gallate (EGCG)
- DrugMicrocrystalline cellulose (MCC)
800mg microcrystalline cellulose (MCC)
- Dietary SupplementAscorbic Acid (Vitamin C)
250mg Ascorbic Acid (Vitamin C) taken one time daily for 12 weeks
Location
- University of RochesterRochester, New York