NCT02195453Unknown4 期
A Randomized,Double-blind,Placebo-Controlled,Multicenter Clinical Trail of Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer
Shandong Cancer Hospital and Institute0 个研究点目标入组 520 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 520
- 主要终点
- Lung Cancer Symptom Scale
研究概览
简要总结
The purpose of this study is to observe quality of life and treatment side effects in patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and Yangzhengxiaoji capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Yangzhengxiaoji Capsule
Experimental
Gemcitabine or Pemetrexed
Cisplatin
Yangzhengxiaoji Capsule four granules t.i.d po
干预措施: Yangzhengxiaoji Capsule (Drug)
Placebo Capsule
Placebo Comparator
Gemcitabine or Pemetrexed
Cisplatin
Placebo Capsule four granules t.i.d po
干预措施: Placebo Capsule (Drug)
结局指标
主要结局
Lung Cancer Symptom Scale
时间窗: 84day
Functional Assessment of Cancer Therapy-Lung scale
时间窗: 84day
次要结局
- Completion of chemotherapy(84 day)
- Progression-free survival(84 day)
- Anti-cancer drugs common grading evaluation of adverse reaction(84day)
- Objective response rate(84day)
研究者
Jinming Yu
Shandong Cancer Hospital and Institute
Shandong Cancer Hospital and Institute
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