NCT01882621Unknown3 期
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.
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- incidence rate of neurotoxicity adverse events
研究概览
简要总结
Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytological and histological confirmation of non-small cell lung cancer (NSCLC) diagnosis, single sputum cytology diagnosis is not accepted
- •Expected survival period is more than 3 months
- •Enough blood function reservation: absolute neutrophil count (ANC) 2 x 10E9/L or higher;platelet count 100 x 109 /L or higher;hemoglobin 9 g/dL or higher.
- •Enough liver function reservation:the total bilirubin less than upper limit of normal;AST and ALT acuities were less than 2.5 times the upper limit of normal (ULN);Alkaline phosphatase 5 times the upper limit of normal (ULN) or less.
- •Clinical doctors identify patients suitable for standard doses of ganglioside drug therapy, and expected time of medication is at least six weeks
- •Within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity; 18 weeks before, did not received platinum-based drugs chemical treatment.
- •No more than 1 degree of the peripheral nervous system diseases exists before enrollment, also no other symptom or disease could affect the adverse reactions of neurotoxicity pathological.
- •Can't accept other adverse reactions may prevent neurotoxicity treatment or care after enrollment.
- •Sign the informed consent form.
排除标准
- •Patients with poor general condition, PS score more than 2 points
- •Women in pregnancy or lactation
- •Patients (male or female) have fertility possibility but not willing to or not to adopt effective contraception
- •With other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity
- •Known or assignment of any of these products to test drugs allergic agent composition
- •Doctors think inappropriate for patients with ganglioside medication or estimated time of less than 6 weeks
- •Active infection (determined by the researcher)
- •According to the researcher's judgment, there is serious disease to endanger the safety of patients, or may prevent the patients from completing the study
- •Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia
研究组 & 干预措施
Monosialoganglioside(GM1)
Active Comparator
Monosialoganglioside(GM1)80mg + N.S 250ml,qd,D0-D3
干预措施: Monosialoganglioside(GM1) (Drug)
normal saline
Placebo Comparator
placebo 80mg + N.S 250ml,qd,D0-D3
干预措施: normal saline (Drug)
结局指标
主要结局
incidence rate of neurotoxicity adverse events
时间窗: up to 19 weeks after cisplatin chemotherapy
次要结局
- neurotoxicity adverse events alleviation time(up to 19 weeks after the cisplatin based chemotherapy)
研究者
Li Zhang
Profressor
Sun Yat-sen University
研究点 (1)
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