drugset / Trial / NCT06524609

EGCG for the Prevention and Treatment of TIPN

NCT06524609

RandomizedParallel-groupDouble-blindTreatment

Summary

Patients treated with paclitaxel analogs and experiencing Taxane-induced peripheral neurotoxicity (TIPN) of degree I or higher were treated with EGCG solution. The safety of topical EGCG solution for the treatment of TIPN and the optimal drug concentration were also verified by a phase I trial. The efficacy and safety of the optimal EGCG concentration obtained in the phase I trial were further analyzed in a randomized controlled phase II trial. Meanwhile, the predictive molecules of TIPN efficacy were initially explored by detecting patients' hematological related indexes. The optimal dose concentration, safety and efficacy of EGCG to ameliorate the neurotoxicity caused by paclitaxel-related drugs were clarified.

Timeline

Start
2023-11-30
Primary completion
2024-11-30
Completion
2025-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject epigallocatechin-3-gallate Unknown 1 % Topical