Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-31 @ 12:39 PM
Study NCT ID:
NCT00363805
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2006-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}, {'id': 'C472086', 'term': 'polyphenon E'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schow@azcc.arizona.edu', 'phone': '520-626-3358', 'title': 'Dr. Sherry Chow', 'organization': 'University of Arizona'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Green Tea', 'description': 'Patients receive green tea beverage and placebo capsules for 6 months.', 'otherNumAtRisk': 42, 'otherNumAffected': 12, 'seriousNumAtRisk': 42, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Polyphenon E', 'description': 'Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.', 'otherNumAtRisk': 63, 'otherNumAffected': 14, 'seriousNumAtRisk': 63, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Patients receive placebo beverage and placebo capsules daily for 6 months.', 'otherNumAtRisk': 73, 'otherNumAffected': 21, 'seriousNumAtRisk': 73, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Flu-like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 13}], 'organSystem': 'General disorders'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'other - knee surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'other - emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'other - pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Flu-like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'pacemaker placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Other - replacement of implant stimulator in abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Other - surgery for unclogging carotid artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Other - knee replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Other - placement of coronary stent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Other - surgery on right ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Other - blood clotting disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urinary 8-hydroxydeoxyguanosine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Tea', 'description': 'Patients receive green tea beverage and placebo capsules for 6 months.'}, {'id': 'OG001', 'title': 'Polyphenon E', 'description': 'Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients receive placebo beverage and placebo capsules daily for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.36', 'spread': '10.48', 'groupId': 'OG000'}, {'value': '5.20', 'spread': '36.20', 'groupId': 'OG001'}, {'value': '-1.08', 'spread': '25.41', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': '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', 'unitOfMeasure': 'ng/mg creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change in Urinary 8-F2-isoprostanes Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Tea', 'description': 'Patients receive green tea beverage and placebo capsules for 6 months.'}, {'id': 'OG001', 'title': 'Polyphenon E', 'description': 'Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients receive placebo beverage and placebo capsules daily for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.87', 'spread': '271.2', 'groupId': 'OG000'}, {'value': '-35.80', 'spread': '261.7', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '266.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': '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', 'unitOfMeasure': 'ng/mg creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Green Tea', 'description': 'Patients receive green tea beverage and placebo capsules for 6 months.'}, {'id': 'FG001', 'title': 'Polyphenon E', 'description': 'Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Patients receive placebo beverage and placebo capsules daily for 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Green Tea', 'description': 'Patients receive green tea beverage and placebo capsules for 6 months.'}, {'id': 'BG001', 'title': 'Polyphenon E', 'description': 'Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Patients receive placebo beverage and placebo capsules daily for 6 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '64.7', 'spread': '8.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2006-08-10', 'resultsFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2006-08-10', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-27', 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urinary 8-hydroxydeoxyguanosine Levels', 'timeFrame': 'Baseline and 6 months', 'description': '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'}, {'measure': 'Change in Urinary 8-F2-isoprostanes Levels', 'timeFrame': 'Baseline and 6 months', 'description': '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'}]}, 'conditionsModule': {'keywords': ['lung cancer', 'prevention', 'green tea', 'former smokers'], 'conditions': ['Lung Cancer Prevention']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* 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.\n* 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.\n\nTertiary\n\n* Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on lung function in these patients.\n* Evaluate the relative adherence to use of green tea beverage vs polyphenon E capsules in these patients.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and inhaled steroid usage (yes vs no).\n\nAll 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.\n\n* Arm I (green tea beverage): Patients receive oral green tea beverage and oral polyphenon E placebo daily for 6 months.\n* Arm II (green tea capsule \\[polyphenon E\\]): Patients receive oral green tea beverage placebo and oral polyphenon E daily for 6 months.\n* Arm III (placebo): Patients receive oral green tea beverage placebo and oral polyphenon E placebo daily for 6 months.\n\nPatients 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.\n\nPROJECTED ACCRUAL: A total of 195 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of chronic obstructive pulmonary disease\n\n * FEV\\_1/FVC ≤ 78\n* History of smoking ≥ 1 pack daily for 30 years OR 2 packs daily for 15 years\n\n * Stopped smoking for ≥ 1 year\n* No previously diagnosed bronchiectasis\n* No history of \\> 1 acute emphysema exacerbation within the past 3 months\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* WBC ≥ 3,500/mm³\n* Platelet count \\> 130,000/mm³\n* Hemoglobin ≥ 11 g/dL (female) or 12 g/dL (male)\n* AST and ALT normal\n* Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease present)\n* Creatinine ≤ 1.5 mg/dL\n* Alkaline phosphatase ≤ 2 times upper limit of normal\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No invasive cancer within the past 5 years\n* Able and willing to consume caffeinated beverages\n* Able to produce induced sputum\n* Able to perform forced expiratory maneuver during spirometry testing\n* No immunosuppression by virtue of medication or disease including, but no limited to, any of the following:\n\n * Organ transplantation\n * Liver or kidney failure\n * Autoimmune diseases\n * Oral steroids\n * Chemotherapy\n* No serious concurrent illness that could preclude study compliance, such as uncontrolled high blood pressure, heart disease, or poorly controlled diabetes\n* No myocardial infarction within the past 6 weeks\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 2 weeks since prior and no concurrent dietary supplements or herbal products, including any of the following:\n\n * Herbal tea\n * Ginkgo biloba \\> 60 mg/day\n * Melatonin \\> 3 mg/day\n * Echinacea \\> 300 mg/day\n * Hypericum perforatum (St. John's wort) \\> 300 mg/day\n * DHEA mustard \\> 5 mg/day\n* At least 2 weeks since prior and no concurrent nontrial tea or tea products\n* More than 3 weeks since prior chest or abdominal surgery\n* More than 3 months since prior participation in chemoprevention or clinical intervention trials\n* At least 3 months since prior and no concurrent megadoses of vitamins, defined as \\> 4,000 IU of vitamin A, 400 IU of vitamin E, 400 IU of cholecalciferol (vitamin D), 60 μg of selenium, or 1,000 mg of ascorbic acid (vitamin C) per day\n* No regular consumption of ≥ 6 cups or glasses of tea per week\n* No concurrent nontrial caffeine at \\> 1 serving/day (1 serving defined as 12 oz of regular soda or 8 oz of coffee)\n* No concurrent participation in another interventional clinical trial"}, 'identificationModule': {'nctId': 'NCT00363805', 'briefTitle': 'Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'CDR0000487501'}, 'secondaryIdInfos': [{'id': 'U01CA101204', 'link': 'https://reporter.nih.gov/quickSearch/U01CA101204', 'type': 'NIH'}, {'id': 'P30CA023074', 'link': 'https://reporter.nih.gov/quickSearch/P30CA023074', 'type': 'NIH'}, {'id': 'UARIZ-HSC-0353'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Green Tea', 'description': 'Patients receive green tea beverage and placebo capsules for 6 months.', 'interventionNames': ['Dietary Supplement: green tea']}, {'type': 'EXPERIMENTAL', 'label': 'Polyphenon E', 'description': 'Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.', 'interventionNames': ['Drug: Polyphenon E']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients receive placebo beverage and placebo capsules daily for 6 months.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'green tea', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given orally', 'armGroupLabels': ['Green Tea']}, {'name': 'Polyphenon E', 'type': 'DRUG', 'description': 'Given orally', 'armGroupLabels': ['Polyphenon E']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Given orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724-5024', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Iman Hakim, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherry Chow', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Sherry Chow', 'investigatorAffiliation': 'University of Arizona'}}}}