NCT02486198

Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

Monosialotetrahexosylganglioside Sodium Injection for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.

Detailed description

Oxaliplatin is widely used in GI cancer. Neutropenia and neurotoxicity are the most common adverse effects of oxaliplatin which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity.The continuous sense and/or motor abnormal reduce the quality of life. To date, there is no a drug to treat oxaliplatin induced neurotoxicity. Monosialotetrahexosylganglioside(GM) 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 investigated for curing OIN in randomized control trial. A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for treatment OIN at GI cancer. Investigators design this randomized phase III placebo-controlled trail to identify the effect of monosialotetrahexosylganglioside sodium injection as a treatment agent for OIN. Investigators found 2.5% patients of grade 2 or more serious OIN would relieve with 3 months(data not published). Investigators assume monosialotetrahexosylganglioside can reduce neurotoxicity by 30%. At the level of power 0.8, the sample size is 160 with 10% dropout. If there is no dropout, the trial will be terminated at 144 events occur.The board of Tianjin cancer hospital has permitted the trial and will monitor the whole process of this study. All data will be submitted to the department of clinic trials at Tianjin cancer hospital.The statistics specialist is participating this design and will afford help for data analysis.

Conditions

• Neurotoxicity

Interventions

Type	Name	Description
DRUG	placebo	1. For patients with oxaliplatin-based chemotherapy(every 2 or 3 weeks), equal saline as placebo should be used one hour before oxaliplatin for 1 week during every chemotherapy cycle, until neurotoxicity progressed. 2. For patients who discontinue oxaliplatin-based chemotherapy, equal saline as placebo should be used daily until there is no neurotoxicity relief (neurotoxicity should be assessed at 2 and 4 weeks' treatment, up to 18 weeks)
DRUG	GM	1. For patients with oxaliplatin-based chemotherapy(every 2 or 3 weeks), monosialotetrahexosylganglioside sodium injection(40mg for chemotherapy of every 2 weeks or 60mg for chemotherapy of every 3 weeks)should be used one hour before oxaliplatin for 1 week during every chemotherapy cycle, until neurotoxicity progressed. 2. For patients who discontinue oxaliplatin-based chemotherapy, equal monosialotetrahexosylganglioside sodium injection should be used daily until there is no neurotoxicity relief (neurotoxicity should be assessed at 2 and 4 weeks' treatment, up to 18 weeks)
DRUG	oxaliplatin-based chemotherapy	chemotherapy contains oxaliplatin

Timeline

• Start date: 2015-05-05
• Primary completion: 2018-01-11
• Completion: 2018-02-02
• First posted: 2015-07-01
• Last updated: 2018-02-05

Locations

1 site across 1 country: China