Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524609
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
EGCG for the Prevention and Treatment of TIPN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study of EGCG for the Prevention and Treatment of Peripheral Neuropathy Induced by Taxane TIPN
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 patients handsfeet with a soft-bristled brush approximately 005 mlcm2 3 times daily and may be covered with film glovescling 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None