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Clinical Trials/NCT04160559
NCT04160559WithdrawnNot Applicable

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 sites in 1 countryStarted: January 11, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
Quality of life (QOL) according to FACT-L (4th edition).

Study Overview

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;

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Time Frame: 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;

Secondary Outcomes

  • 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)

Investigators

Sponsor
Xinqiao Hospital of Chongqing
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jianguo Sun

Clinical Professor

Xinqiao Hospital of Chongqing

Study Sites (2)

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