A Phase 3 interventional study of Monosialoganglioside(GM1) and normal saline in Non-small Cell Lung Cancer, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2016-06-01.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin
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/D1-3, 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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Exclusion Criteria:
Monosialoganglioside(GM1)80mg + N.S 250ml,qd,D0-D3
Drug: Monosialoganglioside(GM1)
placebo 80mg + N.S 250ml,qd,D0-D3
Drug: normal saline
80mg,ivdrip (in the vein) on day 0 - day 3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
Also known as: Monosialotetrahexosylganglioside Sodium Injection
80mg,ivdrip(in the vein) on day 0-3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
incidence rate of neurotoxicity adverse events
Time frame: up to 19 weeks after cisplatin chemotherapy
neurotoxicity adverse events alleviation time
Time frame: up to 19 weeks after the cisplatin based chemotherapy
the quality of life of patients
Time frame: up to 19 weeks after the cisplatin based chemotherapy
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University