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

NCT ID: NCT04160559

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-11
• Study Completion Date: 2020-10-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

chemotherapy plus water

Group Type: PLACEBO_COMPARATOR

green tea

Intervention Type: OTHER

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

Test group

chemotherapy plus green tea

Group Type: EXPERIMENTAL

green tea

Intervention Type: OTHER

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

Interventions

green tea

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role: collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Jianguo Sun

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

Xinqiao Hospital of Chongqing

Chongqing, , China

Countries

China

Other Identifiers

XQonc-013

Identifier Type: -

Identifier Source: org_study_id