Efficacy and Safety of Jing-yuan-kang Granule in the Treatment of Lung Adenocarcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 主要终点
- The quality of life will be evaluated by The European Organization for Research and Treatment of Cancer Quality of life Questinnaire Core-30(EORTC QLQ-C30) scale
研究概览
简要总结
This study is to evaluate the efficacy and safety of Jin-yuan-kang granule in the treatment of lung adenocarcinoma (LUAD) preliminarily, and provide reference for further study.
详细描述
Lung adenocarcinoma (LUAD) is a type of non-small cell lung cancer (NSCLC) with a rapid disease progression and poor treatment effect. The LUAD patients have a short median survival time with 8-11 months. Up to now, chemotherapy is still the first-line treatment for LUAD. PC protocol (pemetrexed + cisplatin) is most commonly used, which is also recommended by NCCN guidelines. However, critical side effects have limited the application and efficacy. Patients will undergo poor quality of life, and the disease will progress rapidly. We still face the stern situation for the treatment of LUAD. It is urgent to develop new treatment and management strategies. Our previous study showed that jing-yuan-kang granule has certain curative effect on LUAD.
This is a multi-certers, randomized, controlled clinical trial to assess the efficacy and safety of Jing-yuan-kang granule in improving quality of life for LUAD patients. After a 2-week wash-out period, a total of 144 LUAD patients will be randomly assigned into experimental or control group with a ratio of 1:1. On the basis of that all the participants will receive PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with no other treatments for control group. The primary outcome is quality of life. The secondary outcomes include Karnofsky (KPS) scores, clinical symptoms, and change of tumor volume. Safety and adverse events will also be assessed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of LADC.
- •Age ranges from17years to75years.
- •A KPS score ≥
- •Without radiotherapy, immunotherapy and targeted therapy.
- •Without participanting in any other trial.
- •With signed informed consent.
排除标准
- •Pregnant, nursing or may become pregnant women.
- •The patient has a history of allergy to any of the components of the intervention drug;
- •Patients with severe liver and kidney dysfunction, cardiovascular and cerebrovascular diseases.
- •Unconscious or unable to communicate normally.
- •Patients with poor compliance.
研究组 & 干预措施
Experimental Group
On the basis of PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with one dose daily.
干预措施: Jing-yan-kang Granule (Drug)
Experimental Group
On the basis of PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with one dose daily.
干预措施: PC chemotherapy and symptomatic treatment (Drug)
Control Group
All the patients in control group will receive PC chemotherapy and symptomatic treatment without other treatment.
干预措施: PC chemotherapy and symptomatic treatment (Drug)
结局指标
主要结局
The quality of life will be evaluated by The European Organization for Research and Treatment of Cancer Quality of life Questinnaire Core-30(EORTC QLQ-C30) scale
时间窗: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
A score of 1-4 will be administrated for each item in EORTC QLQ-C30 . The higher scores will indicate the worse outcomes.
Quality of life will be evaluated by Quality of life Questinnaire Lung Cancer-13(QLQ-LC13)
时间窗: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
次要结局
- Karnofsky(KPS) scores(Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.)
- Change of tumor volume(Change at 12 weeks after treatment compared to baseline.)
- Adverse events will be evaluated and recorded at any time.(at baseline, up to 6 weeks and 12 weeks after treatment.)
- TCM syndrome index(Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.)