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

NCT04160559 | Withdrawn

• 1 other identifier: XQonc-013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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;

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer， green tea, chemotherapy，QOL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Symptom changes assessed by the Lung Cancer Symptom Scale (LCSS).

  4-5 months

• Objective remission rate (ORR) .

  6 months

• progression-free survival (PFS)

  6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

chemotherapy plus water

Other: green tea

Test group

EXPERIMENTAL

chemotherapy plus green tea

Other: green tea

Interventions

green tea OTHER

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

Control group; Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead
• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: collaborator

Study Sites (2)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 40037, China

Location

Xinqiao Hospital of Chongqing

Chongqing, 400000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Tea

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Control group: chemotherapy plus water, test group: chemotherapy plus green tea.

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 13, 2019
• Study Start: January 11, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

CN (2)