drugset / Trial / NCT04538833

GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel

NCT04538833 ↗

Phase 2 Withdrawn Henan Cancer Hospital
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2020-09-09
Primary completion
2022-08-22
Completion
2022-08-22

Outcome

Outcome not reported

Stopped: “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”

Drugs

EvaluationDrugModalityDoseRoute
Subject monosialic gangliosides Unknown 80 mg —