Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-13 @ 9:44 PM
Study NCT ID:
NCT04538833
Status:
WITHDRAWN
Last Update Posted:
2022-11-23
First Post:
2020-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel
Sponsor:
Henan Cancer Hospital
Organization:
Study Overview
Official Title:
Monosialoganglioside in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel : a Multicenter, Double-blind, Randomized Controlled Phase II Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
In the clinical treatment, no patient with a score of less than 38(FACT Ntx Score) points after 1-2 weeks of application of albumin bound paclitaxel in this project, therefore, there is no suitable subject after screening
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Taxane-induced peripheral neuropathy (TIPN) caused by albumin-bound paclitaxel is a dose-limiting toxicity. The main symptoms of discomfort are numbness, tingling, and burning sensations in the glove-sock-like distribution of the limbs. At present, there are few effective methods for clinical treatment of TIPN, and there is no widely agreed consensus on effective treatment in the world. Therefore, it is of great clinical significance and practical value to carry out clinical research to explore drugs to relieve TIPN.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: