We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Oral Green Tea Extract for Small Cell Lung Cancer

This study is currently recruiting participants.
Verified October 2016 by Han Xi Zhao, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
First Posted: March 18, 2011
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Han Xi Zhao, Shandong Cancer Hospital and Institute
The purpose of this study is to determine whether green tea extract is safe for extensive-stage small lung cancer who achieved objective tumor response after first-line therapy.

Condition Intervention Phase
Small Cell Lung Carcinoma Dietary Supplement: epigallocatechin gallate Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase ⅠStudy of Oral Green Tea Extract as Maintenance Therapy for Extensive-stage Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Han Xi Zhao, Shandong Cancer Hospital and Institute:

Primary Outcome Measures:
  • Dose-limiting toxicity as measured by CTCAE [ Time Frame: 4 weeks ]
    Patients receive oral green tea extract twice daily for 4 weeks and be followed closely with physical exams, hematological and biochemical testing. Dose-limiting toxicity was measured by CTCAE. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or un-acceptable toxicity. Cohorts of 3-6 patients receive escalating doses of green tea extract until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Secondary Outcome Measures:
  • progression free survival [ Time Frame: up to 24 weeks ]
  • Determine the effects of EGCG on serum markers: neuron specific enolase (NSE), carcinoma embryonic antigen (CEA) [ Time Frame: up to 24 weeks ]

Estimated Enrollment: 15
Study Start Date: May 2011
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGCG group Dietary Supplement: epigallocatechin gallate
Starting dose green tea catechin extract "EGCG" 400 mg twice a day (BID) of EGCG (400 mg caps BID), second escalated dose 800 mg BID of EGCG (2x400 mg caps BID), third escalated dose 1200 mg BID of EGCG (3x400 mg),fourth escalated dose 1600 mg BID of EGCG (4x400 mg),and fifth escalated dose 2000 mg BID of EGCG (5x400 mg),
Other Name: EGCG

Detailed Description:

Small-cell lung cancer accounts for 13 to 15% of all lung cancer and more than 60 to 70% of patients present with extensive disease (ED). Although etoposide plus cisplatin (EP) regimen has been the mainstay of ED-SCLC treatment, median overall survival is about 9 months, with 5 to 10% surviving two years and only 1% of patients achieving a long-term disease-free survival. To improve this outcome further, various attempts have been made, which included dose intensification with stem cell supports, maintenance therapy, and also searches for a better chemotherapy regimen.

Significant anticarcinogenic effects of green tea extract on various organs, such as skin, stomach, duodenum, colon, liver, pancreas, and lung in rodent models have been confirmed. Recent scientific investigations have identified the active chemical compounds in green tea designated tea polyphenols or catechins. Epigallocatechin-3-gallate (EGCG) is the major catechin in tea.An investigation about the effects of EGCG on human SCLC cells revealed that EGCG had similar anti-tumor effects on drug-sensitive (H69) and drug-resistant (H69VP) SCLC cells. Thus, the investigators conduct this phase I trial, the objectives of this trial were to study the side effects and best dose of of EGCG in treating patients with small-cell lung cancer who achieved objective tumor response after first-line therapy.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of small cell lung cancer
  • extensive-stage disease
  • Eastern Cooperative Oncology Group performance status (PS) of 0 to 2
  • age18 years old
  • Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm^3, platelet count ≥ 100,000 /mm^3, hemoglobin ≥ 9 g/dl
  • Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min
  • Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT & ALST ≤ 1.5 x ULN
  • Signed written informed consent prior to study entry
  • According to Response Evaluation Criteria in Solid Tumors(RECIST), patients didn't progress after first-line chemotherapy

Exclusion Criteria:

  • Any condition that would hamper informed consent or ability to comply with the study protocol
  • Participation in another research study in the last three months
  • Known malignancy at any site other than SCLC
  • Recent consumption of green tea (5 or more cups per day within one week of study enrollment)
  • Pregnant and lactating women
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to EGCG
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317953

Contact: Xindong Sun, M.D. 0086-053167626141 zhx7152028@yahoo.com.cn
Contact: Hanxi Zhao, M.D. 0086-053167626142 171459576@qq.com

China, Shandong
Shan Dong cancer hospital and institute Recruiting
Jinan, Shandong, China, 250117
Contact: Xindong Sun, M.D.    0086053167626141    zhx87520052@163.com.cn   
Contact: Hanxi Zhao, M.D.    0086053167626995    171459576@qq.com   
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Study Director: Xindong Sun, M.D. Shan Dong Tumor Hospital and Institute
  More Information

Responsible Party: Han Xi Zhao, M.D., Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01317953     History of Changes
Other Study ID Numbers: GTESCLC2011
First Submitted: March 17, 2011
First Posted: March 18, 2011
Last Update Posted: October 31, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Epigallocatechin gallate
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents