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Patients receive green tea beverage and placebo capsules for 6 months.

Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.

Patients receive placebo beverage and placebo capsules daily for 6 months.

green tea

Polyphenon E

placebo

Iman Hakim, MD, PhD, MPH

RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea or polyphenon E may prevent cancer from forming in former smokers with chronic obstructive pulmonary disease.

PURPOSE: This randomized phase II trial is studying how well green tea or polyphenon E work in preventing lung cancer in former smokers with chronic obstructive pulmonary disease.

OBJECTIVES:

Primary

* Evaluate the effects of high-level oral consumption of defined green tea (four 12-oz servings/day) or polyphenon E capsules (4 capsules/day) on markers of cellular oxidative damage, as measured by 8-hydroxydeoxyguanosine (8-OHdG) and 8-F_2-isoprostanes (8-epi-PGF2) in former smokers with chronic obstructive pulmonary disease.

Secondary

* Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on body antioxidant status (carotenoids, vitamins A and E, ascorbic acid \[vitamin C\] and antioxidant enzymes \[catalase and glutathione peroxidase\]) in blood in these patients.
* Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on gene expression of markers of proliferation and apoptosis in induced sputum in these patients.

Tertiary

* Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on lung function in these patients.
* Evaluate the relative adherence to use of green tea beverage vs polyphenon E capsules in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and inhaled steroid usage (yes vs no).

All patients receive placebo tea beverage and placebo capsules 4 times a day for 2 weeks. Patients are randomized to 1 of 3 treatment arms after successful completion of the 2-week period.

* Arm I (green tea beverage): Patients receive oral green tea beverage and oral polyphenon E placebo daily for 6 months.
* Arm II (green tea capsule \[polyphenon E\]): Patients receive oral green tea beverage placebo and oral polyphenon E daily for 6 months.
* Arm III (placebo): Patients receive oral green tea beverage placebo and oral polyphenon E placebo daily for 6 months.

Patients undergo blood, urine, exhaled breath condensate (EBC), induced sputum, and buccal cell collection at baseline and periodically during study for biomarker/laboratory analysis. Blood samples are analyzed for 8-hydroxydeoxyguanosine (8-OHdG), glutathione peroxidase, and catalase. Urine is examined for F_2-isoprostanes, 8-OHdG, and tea polyphenols. Induced sputum broncho-epithelial cells are analyzed for gene expression of genes implicated in cellular growth and apoptotic pathway via reverse transcriptase-polymerase chain reaction. EBC samples are examined for F_2-isoprostane levels. Buccal cells are stored for future analysis.

PROJECTED ACCRUAL: A total of 195 patients will be accrued for this study.

Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease

Chemoprevention of Lung Carcinogenesis Using Green Tea: Phase IIb Randomized, Double-Blinded, Placebo Controlled Trial of Green Tea and Polyphenon E in Former Smokers With Chronic Obstructive Lung Disease (COPD)

the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels

the urinary concentrations of 8-F2-isoprostanes were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-F2-isoprostanes levels was calculated as 6 months levels minus baseline levels

National Cancer Institute (NCI)

Sherry Chow

Research Professor

Green Tea

Placebo

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Sherry Chow

The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identify of the analyte was confirmed in the sample.

Change in Urinary 8-hydroxydeoxyguanosine Levels

The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identity of the analyte was confirmed in the sample.

Change in Urinary 8-F2-isoprostanes Levels

Overall Study

Using focus group methodology, investigators will identify and explore new content topics for inclusion in smoking cessation booklets and gather feedback about the existing Stop Smoking for Good booklets regarding tone and message design. Results will be used to modify and adapt the existing cessation intervention.

The SHI arm will receive the intervention developed in Study I.

The UC arm will receive the existing Clearing the Air smoking-cessation manual.

The newly revised Stop Smoking for Good booklets.

Self-Help (SHI)

The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).

Usual Care (UC)

Thomas Brandon, Ph.D.

The purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (CT) scan.

Conduct Formative Research (Months 1 - 4): Identification of emergent themes and responses to existing booklets.

Adapt and Refine Booklets (Months 5 - 8): Advanced drafts of booklets.

Final Reactions to Draft Booklets (Months 9 - 12): Series of smoking cessation booklets for spiral computed tomography (CT) patients.

Capitalizing on a Teachable Moment to Promote Smoking Cessation

Complete formative research to adapt and refine the existing Stop Smoking for Good booklets.

Demand will be estimated by noting accrual rates into the study.

Practicality encompasses the degree to which investigators are able to carry out all the piloted elements of the planned randomized control trial (RCT) successfully and efficiently (i.e., recruitment, screening, randomization, and follow-up).

James and Esther King Biomedical Research Program

H. Lee Moffitt Cancer Center and Research Institute

4 cups/day of green tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water

Green tea

4 cups/day of black tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water

Black tea

4 cups/day of placebo tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water

Placebo tea

The overall objective of this study is to determine the effect of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease	NCT00363805	Lung Cancer Pre...	green tea Polyphenon E placebo	40 Years - 80 Years	University of Arizona
Capitalizing on a Teachable Moment to Promote Smoking Cessation	NCT02276664	Smoking Cessati...	Self-Help (SHI) Usual Care (UC)	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
High Tea Consumption on Smoking Related Oxidative Stress	NCT02719860	Lung Cancer Pre...	Green tea Black tea Placebo tea	40 Years - 80 Years	University of Arizona
Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease	NCT00363805	Lung Cancer Pre...	green tea Polyphenon E placebo	40 Years - 80 Years	University of Arizona

Spots Global Cancer Trial Database for lung cancer prevention