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.
NSCLC patients received a cisplatin-based doublet chemotherapy are included in this trial.
Patients are randomly assigned into the experimental group and control group based on
segmented block randomized method. After enrollment, patients should complete four or six
chemotherapy and GM1/placebo injection. During the 3w per cycle chemotherapy, cisplatin
injection is conducted in D1, GM1/placebo (80mg+250ml N.S) is injected from D0 to D3.
Neurotoxicity evaluation and quality of life (FACT-NTX and EROTC scale) assessment will be
conducted every cycle and 3w/11w/19w after the chemotherapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
incidence rate of neurotoxicity adverse events
up to 19 weeks after cisplatin chemotherapy
LI Zhang, Professor
Sun Yat-sen University
China: Food and Drug Administration