A Randomized, Controlled, Multicenter Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- incidence of neurotoxicity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
monosialoganglioside
patients receive monosialoganglioside.
干预措施: monosialoganglioside (Drug)
结局指标
主要结局
incidence of neurotoxicity
时间窗: up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy
次要结局
- Peripheral nerve conduction velocity(up to 4 weeks after the albumin-bound paclitaxel chemotherapy)
- time(days）neurotoxicity arise(up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy)
研究者
Jian Fang
Director of Thoracic Onconlogy Department
Peking University Cancer Hospital & Institute