drugset / Trial / NCT02024438
Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer
RandomizedParallel-groupDouble-blindPrevention
Summary
For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for chemotherapy. Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse effects which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity. Monosialotetrahexosylganglioside is a component of membrane of nerve cells. Previous phase II clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity(OIN). But it did not certificated by phase III trial. A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at gastric cancer.
Timeline
- Start
- 2013-12
- Primary completion
- 2016-12
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | monosialotetrahexosylganglioside Sodium | Unknown | 40 mg | — |