drugset / Trial / NCT02468739

Effect of GM1 in Prevention of Taxanes Induced Neurotoxicity in Operable Breast Cancer

NCT02468739 ↗

Phase 3 Completed 206 enrolled Sun Yat-sen University
RandomizedParallel-groupTriple-blindPrevention

Summary

Background: Taxane plays a key role in the treatment of breast cancer and taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect leading to treatment discontinuation. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. However, the effects of GM1 on TIPN in breast cancer patients remains unknown. Purpose: This randomized phase III trial is designed to evaluate the potential effects of GM1 for preventing TIPN in breast cancer patients.

Timeline

Start
2015-05
Primary completion
2016-11
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ganglioside-Monosialic Acid Unknown 80 mg Intravenous

Indications