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

Phase 2

• Conditions: Neurotoxicity
• Interventions: Drug: monosialoganglioside

• Registration Number: NCT02500810
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

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

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.

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-11
• Study First Submitted QC: 2015-07-16
• Last Update Submitted: 2015-07-16
• Study First Posted: 2015-07-17
• Last Update Posted: 2015-07-17
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
monosialoganglioside	monosialoganglioside	patients receive monosialoganglioside.

Primary Outcome Measures

Name	Time	Method
incidence of neurotoxicity	up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy

Secondary Outcome Measures

Name	Time	Method
Peripheral nerve conduction velocity	up to 4 weeks after the albumin-bound paclitaxel chemotherapy
time(days）neurotoxicity arise	up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China