Lung Cancer Prevention Clinical Trial
Official title:
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)
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02719860 -
High Tea Consumption on Smoking Related Oxidative Stress
|
Phase 2 |