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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
106
40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGincidence of neurotoxicity
Time frame: up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy
time(days)neurotoxicity arise
Time frame: up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy
Peripheral nerve conduction velocity
Time frame: up to 4 weeks after the albumin-bound paclitaxel chemotherapy
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