RecruitingPhase 2

Reducing Frailty for Older Cancer Survivors Using Supplements II

United States118 participantsStarted 2024-10-25

Plain-language 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.

Who can participate

Age range65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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)
✕. 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).

What they're measuring

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.

Timeframe: 12 Weeks

Trial details

NCT IDNCT06068543

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-01-01

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