This phase II trial compares an epigallocatechin gallate supplement to a placebo for improving symptoms of frailty and inflammation in older cancer survivors. Epigallocatechin gallate is an antioxidant found in some plants such as green and black tea. It prevents free radical damage to cells. A placebo is an inactive substance or treatment that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo. Epigallocatechin gallate may reduce inflammation and other frailty symptoms in older cancer survivors.
Additional locations may be listed on ClinicalTrials.gov for NCT06068543.
Locations matching your search criteria
United States
New York
Rochester
University of RochesterStatus: Active
Contact: Nikesha Gilmore
Phone: 585-275-1275
PRIMARY OBJECTIVE:
I. To evaluate the preliminary efficacy of the epigallocatechin gallate (EGCG) intervention versus (vs.) placebo on physical frailty (Short Physical Performance Battery) in older cancer survivors.
MECHANISTIC OBJECTIVES:
I. To evaluate the preliminary efficacy of the EGCG intervention vs. placebo on tumor necrosis factor-alpha (TNF-α) and related immune markers in older cancer survivors.
II. To explore if baseline TNF-α and related immune markers and DNAmage (epigenetic age) are associated with baseline and post-intervention physical frailty in older cancer survivors.
DIVERSITY, EQUITY, AND INCLUSION OBJECTIVE:
I. To explore the efficacy of the EGCG intervention vs. placebo on physical frailty and TNF-α and related immune markers in older Black vs. white cancer survivors after adjusting for the effects of psychosocial stressors (e.g. depression, anxiety).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive EGCG and vitamin C orally (PO) once daily (QD) for 12 weeks. Patients also undergo collection of blood samples throughout the trial.
ARM 2: Patients receive placebo cellulose, microcrystalline and vitamin C PO QD for 12 weeks. Patients also undergo collection of blood samples throughout the trial.
After completion of study intervention, patients are followed up at week 13.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Rochester
Principal InvestigatorNikesha Gilmore
