RecruitingPhase 1Phase 2NCT06524609

EGCG for the Prevention and Treatment of TIPN

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


Sponsor

Han Xi Zhao

Enrollment

36 participants

Start Date

Nov 30, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Alcohol and a drug called Epigallocatechin-3-Gallate for people with chemotherapy induced peripheral neuropathy. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEpigallocatechin-3-Gallate

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

DRUGAlcohol

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

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NCT06524609


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