Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

Phase 3

Completed

• Conditions: Neurotoxicity
• Interventions: Drug: placebo; Drug: GM; Drug: oxaliplatin-based chemotherapy

• Registration Number: NCT02486198
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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 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.

Study Timeline

• Status Verified: 2015-05
• Study First Submitted: 2015-05-03
• Study Start: 2015-05-05
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-01
• Primary Completion: 2018-01-11
• Study Completion: 2018-02-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

1. Patients shall have normal organic function such as liver function, Cardiac function and renal function;
2. male or female age >18 years old;
3. diagnosis GI cancer with histology;
4. Chronic neurotoxicity grade is 2 or more
5. Karnofsky Performance scores should be 80 or more
6. patients are in oxaliplatin-based chemotherapy courses or no more than 21 days after last oxaliplatin usage for patients who will discontinue oxaliplatin usage.
7. without uncured tumor except GI cancer,
8. Patients should be expected to live no shorter than 3 months

Exclusion Criteria

1. patients who is receiving anti-neurotoxicity treatment;
2. WBC<4.0×109/L，ANC<1.5×109/L,PLT<100×109/L，Hb<90g/L,TBIL>1.5Limitation;BUN）>1.5Limitation；Cr）>1.5Limitation；ALT or AST>2.5Limitation（without liver metastasis）；ALT or AST）>5Limitation（with liver metastasis）;
3. heart dysfunction;
4. brain metastasis with symptoms;
5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
6. in situation of oxaliplatin-based chemotherapy progressed, the next chemotherapy regime should not contain agents which will cause neurotoxicity (such as paclitaxel and cisplatin)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo+oxaliplatin-based chemotherapy	oxaliplatin-based chemotherapy	equal saline as placebo, one hour before chemotherapy (if with chemotherapy) with oxaliplatin-based chemotherapy (every 2 or 3 weeks), or daily use until neurotoxicity progress.
placebo+oxaliplatin-based chemotherapy	placebo	equal saline as placebo, one hour before chemotherapy (if with chemotherapy) with oxaliplatin-based chemotherapy (every 2 or 3 weeks), or daily use until neurotoxicity progress.
GM+oxaliplatin-based chemotherapy	GM	monosialotetrahexosylganglioside Sodium Injection, 40mg or 60mg, one hour before chemotherapy (if with chemotherapy) with oxaliplatin-based chemotherapy (every 2 or 3 weeks), or daily use until neurotoxicity progress.
GM+oxaliplatin-based chemotherapy	oxaliplatin-based chemotherapy	monosialotetrahexosylganglioside Sodium Injection, 40mg or 60mg, one hour before chemotherapy (if with chemotherapy) with oxaliplatin-based chemotherapy (every 2 or 3 weeks), or daily use until neurotoxicity progress.

Primary Outcome Measures

Name	Time	Method
The relief of neurotoxicity in patients with grade 2 or higher neurotoxicity by means of CTC 4.03 and EORTC QLQ-CIPN20	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 modified EORTC QLQ-CIPN20, patients will evaluate the neurotoxicity relief extent on the Visual Analog Scale

Secondary Outcome Measures

Name	Time	Method
quality of life	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
Safety of Monosialotetrahexosylganglioside sodium injection in treatment of Oxaliplatin induced Neurotoxicity in Gastrointestinal cancer as measured by the number of any adverse effect	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

Trial Locations

Locations (1)

TianjinCIH; 🇨🇳 Tianjin, Tianjin, China