Clinical Trial: Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: 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. 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.
Sponsor: Tianjin Medical University Cancer Institute and Hospital

Current Primary Outcome: The relief of neurotoxicity in patients with grade 2 or higher neurotoxicity by means of CTC 4.03 and EORTC QLQ-CIPN20 [ Time Frame: From the time recruited to neurotoxicity progressed(assesse before chemotherapy) or without relief(assess at week 2 and 4, up to 18 weeks) ]

Besides CTC 4.03 and EORTC QLQ-CIPN20, patients will evaluate the neurotoxicity relief extent on the Visual Analog Scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety of Monosialotetrahexosylganglioside sodium injection in treatment of Oxaliplatin induced Neurotoxicity in Gastrointestinal cancer as measured by the number of any adverse effect [ Time Frame: every 2 or 3 weeks during GM usage and will continue to assess every 3 months, up to 1 year ]
    The number of any adverse effect will be used to assess safety
  • quality of life [ Time Frame: evaluate 1 week before interventions'usage and every 4 weeks , up to 24 weeks. And evaluate once within 4 weeks after the patients out of the study ]
    investigators use sf-36 to evaluated the quality of life


Original Secondary Outcome: Same as current

Information By: Tianjin Medical University Cancer Institute and Hospital

Dates:
Date Received: May 3, 2015
Date Started: May 2015
Date Completion: May 2020
Last Updated: June 30, 2015
Last Verified: May 2015