NCT04160559

Green Tea Combined With Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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;

Detailed description

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;

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	green tea	The investigators require patients to regularly drink green tea during the trial period.

Timeline

• Start date: 2020-01-11
• Primary completion: 2020-10-30
• Completion: 2020-10-30
• First posted: 2019-11-13
• Last updated: 2021-09-08

Locations

2 sites across 1 country: China