Clinical trial · Interventional
Monosialoganglioside Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients
A Randomized, Controlled, Multicenter Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients
NCT02500810CI-TRIAL-00018573unknownPhase 2ClinicalTrials.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 monosialoganglioside are effective in the prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer patients, and improve the quality of life of patients.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monosialoganglioside | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- monosialoganglioside
- description
- patients receive monosialoganglioside.
- interventionNames
- Drug: monosialoganglioside
- type
- NO_INTERVENTION
- label
- control
- description
- blank control
Primary outcomes (1)
- measure
- incidence of neurotoxicity
- timeFrame
- up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytological and histological confirmation of unresectable locally advanced or metastatic lung cancer diagnosis * No peripheral nervous system diseases exists before * Within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity * Enough organ functions reservation and appropriate performance status for chemotherapy * Expected survival period is more than 3 months Exclusion Criteria: * Known or assignment of any of these products to test drugs allergic agent composition * With peripheral neuropathy by any cause before treatment * With other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity * Patients with poor general condition to receive chemotherapy * Genetic glucolipid metabolic abnormalities * Patients (male or female) have fertility possibility but not willing to or not to adopt effective contraception * Patients cann't avoid neurotrophic drugs * According to the researcher's judgment, the situations inappropriate for patients with ganglioside medication
References
Publications (0)
Data not yet available
No reference posted for this study.