NCT02024438

Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer

The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

it is a placebo controlled phase III trial. Investigators plan to enroll 240 patients with 1:1 to A arm and B arm

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	monosialotetrahexosylganglioside Sodium	it is extracted from pig's brain,shenjie is the brand name
OTHER	placebo	saline of the same appearance as monosialotetrahexosylganglioside Sodium

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2013-12-31
• Last updated: 2015-09-28

Locations

2 sites across 1 country: China