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RECRUITING
NCT06524609
PHASE1/PHASE2

EGCG for the Prevention and Treatment of TIPN

Sponsor: Han Xi Zhao

View on ClinicalTrials.gov

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.

Official title: Clinical Study of EGCG for the Prevention and Treatment of Peripheral Neuropathy Induced by Taxane (TIPN)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-11-30

Completion Date

2025-01-30

Last Updated

2024-07-29

Healthy Volunteers

No

Interventions

DRUG

Epigallocatechin-3-Gallate

After determining the optimal dose, the efficacy of EGCG was compared with that of a control group (75% alcohol).

DRUG

Alcohol

After determining the optimal dose, the efficacy of EGCG was compared with that of a placebo control group (75% alcohol).

Locations (1)

Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences)

Jinan, Shandong, China