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Oral Green Tea Extract for Small Cell Lung Cancer

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. Identifier: NCT01317953
Expanded Access Status : Available
First Posted : March 18, 2011
Last Update Posted : April 5, 2019
Information provided by (Responsible Party):
Han Xi Zhao, Shandong Cancer Hospital and Institute

Brief Summary:
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 or disease Intervention/treatment
Small Cell Lung Carcinoma Dietary Supplement: epigallocatechin gallate

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.

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Study Type : Expanded Access
Official Title: Phase ⅠStudy of Oral Green Tea Extract as Maintenance Therapy for Extensive-stage Small Cell Lung Cancer

Intervention Details:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01317953

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Contact: Xindong Sun, M.D. 0086-053167626141
Contact: Hanxi Zhao, M.D. 0086-053167626142

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China, Shandong
Shan Dong cancer hospital and institute
Jinan, Shandong, China, 250117
Contact: Xindong Sun, M.D.    0086053167626141   
Contact: Hanxi Zhao, M.D.    0086053167626995   
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
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Study Director: Xindong Sun, M.D. Shan Dong Tumor Hospital and Institute

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Responsible Party: Han Xi Zhao, M.D., Shandong Cancer Hospital and Institute Identifier: NCT01317953     History of Changes
Other Study ID Numbers: GTESCLC2011
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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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