Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

May 5, 2015

Primary Completion Date

January 11, 2018

Study Completion Date

February 2, 2018

Conditions
Neurotoxicity
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

Trial Locations (1)

300060

TianjinCIH, Tianjin

All Listed Sponsors
lead

Tianjin Medical University Cancer Institute and Hospital

OTHER

NCT02486198 - Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer | Biotech Hunter | Biotech Hunter