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RecruitingInterventionalPhase 2
A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
NCT ID: NCT06068543Sponsor: University of RochesterLast updated: 2026-03-06
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.
Arms & 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
Outcome measures
Primary
Change of physical frailty measured using the Short Physical Performance Battery (SPPB) in patients in the EGCG arm compared to placebo; change in SPPB scores from baseline to 12 weeks.
We will assess the change in SPPB scores from baseline to 12 weeks after baseline in patients in the EGCG intervention arm compared to the placebo arm.
Time frame: 12 Weeks
Eligibility criteria
Sex: AllAge: 65 Years and olderHealthy 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 screening)
* 3 times institutional upper limit of normal for ALT and AST
* 1.5 times institutional upper limit of normal for bilirubin
3. Have uncontrolled or unmanaged liver disease.
4. Consume more than 6 cups of green tea per day.
5. Have known allergies to caffeine.
6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
7. Be diagnosed with dementia.
8. Cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist).
Study locations (1)
University of Rochester
Rochester, New York, 14627