Monosialoganglioside Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Lung cancer patients received a single-agent albumin-bound paclitaxel chemotherapy are included in this trial. Patients are randomly assigned into the experimental group and blank control group based on segmented block randomized method. After enrollment, patients will complete at least chemotherapy and GM1 injection/blank control. During the 3w per cycle chemotherapy, albumin-bound paclitaxel is conducted in D1 and D8, GM1(40mg+250ml N.S) is injected from D1 to D8. Neurotoxicity evaluation and quality of life assessment will be conducted every cycle and 3m/6m after the chemotherapy.

Official Title
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A Randomized, Controlled, Multicenter Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients

Conditions
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Neurotoxicity

Intervention / Treatment
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* Drug: monosialoganglioside


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: monosialoganglioside<br>patients receive monosialoganglioside. | Drug: monosialoganglioside<br>* 40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles.<br>* Other names: Monosialotetrahexosylganglioside Sodium Injection;|
| No Intervention: control<br>blank control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of neurotoxicity |  | up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time(days）neurotoxicity arise |  | up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy | 
| Peripheral nerve conduction velocity |  | up to 4 weeks after the albumin-bound paclitaxel chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurotoxicity, chemotherapy, monosialoganglioside, prevention