A Phase 1/2 interventional study of Epigallocatechin-3-Gallate and Alcohol in Chemotherapy-induced Peripheral Neuropathy, sponsored by Han Xi Zhao. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Han Xi Zhao · Phase 1/2, Interventional, and Treatment
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.
Enrolled patients with tumors that developed CIPN of degree II or greater who received albumin-bound paclitaxel chemotherapy. The baseline degree of CIPN in patients was evaluated by CTCAE and TNS as well as the EORTC-CIPN20 scale. EGCG was purchased from HEP Biotech Co., Ltd (Ningbo, Zhejiang, China) and freshly dissolved in 75% alcohol by volume. EGCG concentrations were climbed from 1% according to the modified Fibonacci method for 4 dose groups. EGCG administration was initiated when Grade II CIPN occurred first time. EGCG solution is applied to the patient's hands/feet with a soft-bristled brush, approximately 0.05 ml/cm2. 3 times daily, and may be covered with film gloves/cling film for approximately 20-30 minutes after application. Use continuously for at least 1 week. By comparing and analyzing the degree of reduction in CECAE, TNS, and EORTC scale data before and after EGCG treatment in patients with degree II CIPN, the optimal EGCG drug dosing concentration was obtained to validate safety. The EGCG concentration obtained from the phase I trial was also used to prospectively conduct a randomized controlled phase II clinical trial to further validate the efficacy.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
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Exclusion Criteria:
EGCG administration was initiated when Grade II CIPN occurred first time. EGCG solution is applied to the patient's hands/feet with a soft-bristled brush, approximately 0.05 ml/cm2. 3 times daily, and may be covered with film gloves/cling film for approximately 20-30 minutes after application. Use continuously for at least 1 week.
Drug: Epigallocatechin-3-Gallate
75% alcohol
Drug: Alcohol
After determining the optimal dose, the efficacy of EGCG was compared with that of a control group (75% alcohol).
After determining the optimal dose, the efficacy of EGCG was compared with that of a placebo control group (75% alcohol).
sensory nerves and motor nerves of CTCAE
CTCAE(Common Terminology Criteria for Adverse Events): A minimum of 1 grade and maximum of 5 grades.
Time frame: 42 days
TNS(Total Neuropathy Score)
TNS(Total Neuropathy Score): Including sensory nerves, motor nerves and tendon reflexes, etc., 10 indicators, with a minimum of 1 grade and maximum of 5 grades each, and the scores of the 10 indicators were added together for a total.
Time frame: 42 days
EORTC Scale(European Organization for Research and Treatment of Cancer TIPN-specific Quality of Life Quality of Life Questionnaire for CIPN)
The scale consists of 9 scales for sensory, motor, and autonomic nerves, same grading and calculation method as the TNS scale.
Time frame: 42 days
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