Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

Summary

The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.

Timeline

Start

2015-05-05

Primary completion

2018-01-11

Completion

2018-02-02

Outcome

Met primary endpoint

paper More patients responded in the GM1 group than in the placebo group (MCIPN responders: 53% vs 14% PMID 34765950 ↗

paper MCIPN responders: 53% vs 14%, VAS responders: 49% vs 22%, double responders: 41% vs 7%, and high responders: 32% vs 13%, all P < ·01. PMID 34765950 ↗

Publications

• Zhou L, Liu R, Huang D, Li H, Ning T, Zhang L, Ge S, Bai M, Wang X, Yang Y, Wang X, Chen X, Gao Z, Luo L, Yang Y, Wu X, Deng T, Ba Y. Monosialotetrahexosylganglioside in the treatment of chronic oxaliplatin-induced peripheral neurotoxicity: TJMUCH-GI-001, a randomised controlled trial. EClinicalMedicine. 2021 Oct 29;41:101157. doi: 10.1016/j.eclinm.2021.101157. eCollection 2021 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	monosialotetrahexosylganglioside Sodium	Unknown	40 mg	—
Subject	monosialotetrahexosylganglioside Sodium	Unknown	60 mg	—
Background	Oxaliplatin	Small molecule	—	—

Indications