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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04160559
• Other study ID #: XQonc-013
• Status: Withdrawn
• Phase: N/A
• Start date: January 11, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: August 2021
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

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;

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with pathologically confirmed NSCLC have evaluable lesions.

• ECOG PS:0-2??

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Other:
• green tea
The investigators require patients to regularly drink green tea during the trial period.

Locations

Country	Name	City	State
China	the second affiliated hospital of Army medical university	Chongqing	Chongqing
China	Xinqiao Hospital of Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QOL) 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;	4-5 months
Secondary	Symptom changes assessed by the Lung Cancer Symptom Scale (LCSS).	A clinically significant change in symptoms was defined as a change in LCSS score from baseline = 2 points, < 2 points defined as no clinically significant change.	4-5 months
Secondary	Objective remission rate (ORR) .	Objective remission rate (ORR)	6 months
Secondary	progression-free survival (PFS)	progression-free survival (PFS)	6 months