Clinical trial · Interventional
Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by First-line Chemotherapy Contained Cisplatin in Non-small Cell Lung Cancer Patients.
NCT01882621CI-TRIAL-00022430unknownPhase 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)
Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monosialoganglioside(GM1) | Drug | — | UNRESOLVED |
| normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Monosialoganglioside(GM1)
- description
- Monosialoganglioside(GM1)80mg + N.S 250ml,qd,D0-D3
- interventionNames
- Drug: Monosialoganglioside(GM1)
- type
- PLACEBO_COMPARATOR
- label
- normal saline
- description
- placebo 80mg + N.S 250ml,qd,D0-D3
- interventionNames
- Drug: normal saline
Primary outcomes (1)
- measure
- incidence rate of neurotoxicity adverse events
- timeFrame
- up to 19 weeks after cisplatin chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Cytological and histological confirmation of non-small cell lung cancer (NSCLC) diagnosis, single sputum cytology diagnosis is not accepted * Expected survival period is more than 3 months * Enough blood function reservation: absolute neutrophil count (ANC) 2 x 10E9/L or higher;platelet count 100 x 109 /L or higher;hemoglobin 9 g/dL or higher. * Enough liver function reservation:the total bilirubin less than upper limit of normal;AST and ALT acuities were less than 2.5 times the upper limit of normal (ULN);Alkaline phosphatase 5 times the upper limit of normal (ULN) or less. * Clinical doctors identify patients suitable for standard doses of ganglioside drug therapy, and expected time of medication is at least six weeks * Within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity; 18 weeks before, did not received platinum-based drugs chemical treatment. * No more than 1 degree of the peripheral nervous system diseases exists before enrollment, also no other symptom or disease could affect the adverse reactions of neurotoxicity pathological. * Can't accept other adverse reactions may prevent neurotoxicity treatment or care after enrollment. * Sign the informed consent form. Exclusion Criteria: * Patients with poor general condition, PS score more than 2 points * Women in pregnancy or lactation * Patients (male or female) have fertility possibility but not willing to or not to adopt effective contraception * With other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity * Known or assignment of any of these products to test drugs allergic agent composition * Doctors think inappropriate for patients with ganglioside medication or estimated time of less than 6 weeks * Active infection (determined by the researcher) * According to the researcher's judgment, there is serious disease to endanger the safety of patients, or may prevent the patients from completing the study * Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia
References
Publications (0)
Data not yet available
No reference posted for this study.