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EGCG for the Prevention and Treatment of TIPN
Sponsor: Han Xi Zhao
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
Epigallocatechin-3-Gallate
After determining the optimal dose, the efficacy of EGCG was compared with that of a control group (75% alcohol).
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