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临床试验/NCT04160559
NCT04160559撤回不适用

Green Tea Combined With Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer: A Randomized, Controlled Multicenter Clinical Study

Xinqiao Hospital of Chongqing2 个研究点 分布在 1 个国家开始时间: 2020年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Quality of life (QOL) according to FACT-L (4th edition).

研究概览

简要总结

Patients with non-small cell lung cancer who met the inclusion and exclusion criteria were screened and randomly divided into control group and experimental group. Control group: chemotherapy plus water ,test group: chemotherapy plus green tea.

Primary endpoint: Assessment of changes in quality of life (QOL) after chemotherapy according to FACT-L (4th edition). A clinically significant change in the quality of life of lung cancer was defined as a FACT-L score change of ≥6 points from baseline, with <6 points defined as no clinically significant changes;

详细描述

Patients with non-small cell lung cancer who met the inclusion and exclusion criteria were screened and randomly divided into control group and experimental group. Control group: chemotherapy plus water (at least 3-5 cups per day, 100-120ml per cup), test group: chemotherapy plus green tea (patients drink tea from the beginning to the end of the test, patients drink moderately concentration of green tea 3-5 cups per day, 100-120ml per cup, and the monthly tea consumption is ≥100g. The tea concentration is defined that the amount of tea in the cup after boiling water is 50% or more which is "strong tea", 25% to 50% is "moderately concentrated tea", and less than 25% is "light tea"). The number of days of tea drinking by the patient is greater than or equal to 18 days per chemotherapy cycle.The quality of life of patients was assessed according to the Lung Cancer Quality of Life Scale (FACT-L (4th Edition)) and the Lung Cancer Symptom Scale (LCSS). Pre-chemotherapy quality of life scores were used as baseline. The evaluation was performed once before each chemotherapy, and the final quality of life assessment was performed within 1-4 weeks after the end of the fourth cycle of chemotherapy. A total of 5 quality of life assessments were completed. If the patient's condition progresses during chemotherapy, the assessment endpoint is when the disease progresses. Primary endpoint: Assessment of changes in quality of life (QOL) after chemotherapy according to FACT-L (4th edition). A clinically significant change in the quality of life of lung cancer was defined as a FACT-L score change of ≥6 points from baseline, with <6 points defined as no clinically significant changes;

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

入选标准

  • Patients with pathologically confirmed NSCLC have evaluable lesions.
  • ECOG PS:0-2 分。
  • Unintentional liver and kidney and other organic diseases, no other primary malignant tumors.
  • Patients with clinical stage IIIB and IV who are scheduled for chemotherapy (first or second line).

排除标准

  • Patients who have long-term tea drinking habits (more than 4 cups of green tea per day).
  • Patients who have used immunological checkpoint inhibitors for more than 50%. Pregnant or lactating woman.
  • The investigator judges other conditions that may affect the clinical research and the judgment of the research results.

结局指标

主要结局

Quality of life (QOL) according to FACT-L (4th edition).

时间窗: 4-5 months

A clinically significant change in the quality of life of lung cancer was defined as a FACT-L score change of ≥6 points from baseline, with \<6 points defined as no clinically significant changes;

次要结局

  • progression-free survival (PFS)(6 months)
  • Objective remission rate (ORR) .(6 months)
  • Symptom changes assessed by the Lung Cancer Symptom Scale (LCSS).(4-5 months)

研究者

发起方
Xinqiao Hospital of Chongqing
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianguo Sun

Clinical Professor

Xinqiao Hospital of Chongqing

研究点 (2)

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