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Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

NCT02486198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2018-02-05

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Yi Ba, MD.PHD · Tianjin Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-05
Primary Completion
2018-01-11
Completion
2018-02-02

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02486198 on ClinicalTrials.gov