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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

Antineoplastic Agents

Other Dietary Supplements

Sulforaphane

Protective Agents

Sulforaphane four tablets 2 times per day with breakfast and dinner each dose contains approximately 120 micromole of Sulforaphane

Placebo (containing no active drug) four tablets 2 times per day with breakfast and dinner

Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables.

Jian-Min Yuan, MD, PhD

This research study involves taking an experimental anti-cancer dietary supplement called Sulforaphane (SF) or a placebo (product without any supplement content) over a period of twelve months in order to determine if it is a useful dietary supplement for prevention of lung cancer in humans.

The main goals of this research study are:

1. To learn about the effects of giving Sulforaphane (SF) to former smokers who are still at high risk of developing cancer due to their smoking history and whether or not their condition improves, stays the same or becomes worse after Sulforaphane (SF) is given.
2. To learn whether Sulforaphane (SF) might reverse some of the lung cell changes associated with future development of lung cancer.

Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers

Randomized Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers

To explore if daily oral dose of 120 micromole SF can modulate the changes in bronchial dysplasia from endoscopic biopsies in former smokers at high risk for lung cancer.

To explore if daily oral dose of 120 micromole SF can inhibit level of cell proliferation marker Ki-67 in bronchial biopsies of former smokers at high risk for lung cancer.

To explore if daily oral dose of 120 micromole SF can induce apoptosis markers caspase-3 and TUNEL in bronchial biopsies in former smokers at high risk for lung cancer.

To explore if daily oral dose of 120 micromole SF can modulate the changes of the lung cancer-related gene expression markers in bronchial epithelia in former smokers at high risk for lung cancer.

To explore if daily oral dose of 120 micromole SF can modulate the changes of bronchial premalignant lesions-related gene expression markers in former smokers at high risk for lung cancer.

To explore if daily oral dose of 120 micromole SF can modulate the similar changes of the gene expression markers in nasal epithelia.

To determine the safety and toxicity of daily oral dose of 120 micromole SF in former smokers at high risk for lung cancer by monitoring and recording any potential SF-related adverse events (both expected and unexpected events).

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
Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers	NCT03232138	Lung Cancer	Sulforaphane Placebo	55 Years - 75 Years	University of Pittsburgh
Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers	NCT03232138	Lung Cancer	Sulforaphane Placebo	55 Years - 75 Years	University of Pittsburgh
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
Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers	NCT03232138	Lung Cancer	Sulforaphane Placebo	55 Years - 75 Years	University of Pittsburgh

Spots Global Cancer Trial Database for former smokers