The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- progression-free survival rate
研究概览
简要总结
To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation
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
- 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
- •Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age > 18 ages
- •Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤
- •White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L
- •ALT, AST, normal or less than 2 times, bilirubin is normal
- •Serum level in the normal range;Thr ecg is normal
- •Expected survival time≥ 3 months or more;
- •Agreed to the treatment combined traditional Chinese medicine with western medicine
排除标准
- •Engaged in other clinical subjects
- •Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail
- •Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor
- •Severe damage of heart, liver and kidney (cardiac function grade 3 ~ 4, ALT and/or AST 2 times more than normal , Cr more the normal limit)
- •Mental illness, Refused to partner; Cannot obtain informed consent
研究组 & 干预措施
Chemotherapy combined with compound herbal medicine
Standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks combined with compound Chinese herbal medicine for 2 years，which include 15 kinds of Chinese herbs:Thunberg fritillary bulb,antimutangenic ,cimicifuga foetida,astragalus,pinellia ,Radix Ophiopogonis ,Solanum nigrum,Hedyotis diffusa,Prunella vulgaris ,cordate houttuynia,Herba Patriniae,dried orange peel ,Codonopsis,Wolfiporia extensa,Coix seed,Rhizoma Alismatis.
干预措施: standard chemotherapy medicine combined with Chinese herbs (Drug)
Chemotherapy
The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks
干预措施: standard chemotherapy medicine (Drug)
结局指标
主要结局
progression-free survival rate
时间窗: 36months
Overall survival rate
时间窗: 36months
次要结局
未报告次要终点
研究者
Sun Bao-guo
Principal Investigator
First Affiliated Hospital, Sun Yat-Sen University