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EGCG for the Prevention and Treatment of TIPN

NCT06524609 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-07-29

No results posted yet for this study

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.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

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).

Sponsors & Collaborators

  • The Fourth People's Hospital of Jinan

    collaborator UNKNOWN

  • Han Xi Zhao

    lead OTHER

Principal Investigators

  • Hanxi Zhao, Dr. · Institute of Radiation Medicine, Shandong First Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524609 on ClinicalTrials.gov