Clinical trial · Interventional
Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer
Monosialotetrahexosylganglioside Sodium Injection for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer
NCT02486198CI-TRIAL-00031545completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM | Drug | — | UNRESOLVED |
| oxaliplatin-based chemotherapy | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- placebo+oxaliplatin-based chemotherapy
- description
- 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.
- interventionNames
- Drug: placebo
- Drug: oxaliplatin-based chemotherapy
- type
- EXPERIMENTAL
- label
- GM+oxaliplatin-based chemotherapy
- description
- 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.
- interventionNames
- Drug: GM
- Drug: oxaliplatin-based chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDZhou L, Liu R, Huang D, Li H, Ning T, Zhang L, Ge S, Bai M, Wang X, Yang Y, Wang X, Chen X, Gao Z, Luo L, Yang Y, Wu X, Deng T, Ba Y. Monosialotetrahexosylganglioside in the treatment of chronic oxaliplatin-induced peripheral neurotoxicity: TJMUCH-GI-001, a randomised controlled trial. EClinicalMedicine. 2021 Oct 29;41:101157. doi: 10.1016/j.eclinm.2021.101157. eCollection 2021 Nov. PMID 34765950