Reducing Frailty for Older Cancer Survivors Using Supplements II

Paused · Phase 2

Conditions studied: Frailty, Inflammation

In brief

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.

Key facts

Study ID

NCT06068543

Run by

University of Rochester

People needed

118

Starts

2024-10-25

Expected to finish

2030-12-31

Last updated by the study team

2026-06-26

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 1.5 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).

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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