drugset / Trial / NCT02468739
Effect of GM1 in Prevention of Taxanes Induced Neurotoxicity in Operable Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ganglioside-Monosialic Acid | Unknown | 80 mg | Intravenous |