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

Peking University Cancer Hospital & Institute

Status and phase

Unknown

Phase 2

Conditions

Neurotoxicity

Treatments

Drug: monosialoganglioside

Study type

Interventional

Funder types

Other

Identifiers

NCT02500810

GW-N-1501

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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