Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-28 @ 3:52 PM
Study NCT ID:
NCT00691132
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2008-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phenethyl Isothiocyanate in Preventing Lung Cancer in Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C058305', 'term': 'phenethyl isothiocyanate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hatsu001@umn.edu', 'phone': '612-626-2121', 'title': 'Dr. Dorothy Hatsukami', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Short-term Trial)', 'description': 'Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.\n\nphenethyl isothiocyanate: Given orally\n\nplacebo: Given orally', 'otherNumAtRisk': 107, 'otherNumAffected': 66, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Washout', 'description': '9 days between treatments', 'otherNumAtRisk': 107, 'otherNumAffected': 35, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PEITC (Short-term Trial)', 'description': 'Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.\n\nphenethyl isothiocyanate: Given orally\n\nplacebo: Given orally', 'otherNumAtRisk': 107, 'otherNumAffected': 107, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GI tract', 'notes': 'Most common were dry mouth, taste alteration, stomachache, belching, flatulence, and diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 103, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 35, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 107, 'numEvents': 284, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 35, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 107, 'numEvents': 58, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constitutional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 24, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numEvents': 24, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urinary Levels of Biomarkers of NNK Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEITC-Placebo', 'description': 'Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 1 and oral placebo four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.'}, {'id': 'OG001', 'title': 'Placebo - PEITC', 'description': 'Participants receive oral placebo four times daily for 5 days in Period 1 and oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.'}], 'classes': [{'title': 'Period 1 - Total ITC', 'categories': [{'measurements': [{'value': '42.8', 'groupId': 'OG000', 'lowerLimit': '37.4', 'upperLimit': '48.9'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.19', 'upperLimit': '0.54'}]}]}, {'title': 'Period 2 - Total ITC', 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '0.46'}, {'value': '49.7', 'groupId': 'OG001', 'lowerLimit': '43.2', 'upperLimit': '57.2'}]}]}, {'title': 'Period 1 - PEITC-NAC', 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '46.3', 'upperLimit': '69.3'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.48'}]}]}, {'title': 'Period 2 - PEITC-NAC', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.85'}, {'value': '68.1', 'groupId': 'OG001', 'lowerLimit': '56.6', 'upperLimit': '81.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 periods, 5 days each on PEITC or Placebo, with washout week between', 'description': 'Urinary levels of Total ITC and PEITC-NAC by treatment sequence groups and treatment period.', 'unitOfMeasure': 'pmol/mg creatinine', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Urinary Levels of Biomarkers of NNK Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants receive oral placebo four times daily for 5 days in either Period 1 or Period 2.'}, {'id': 'OG001', 'title': 'PEITC', 'description': 'Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in either Period 1 or Period 2.'}], 'classes': [{'title': 'Total [pyridine-D4]NNAL', 'categories': [{'measurements': [{'value': '0.366', 'groupId': 'OG000', 'lowerLimit': '0.286', 'upperLimit': '0.396'}, {'value': '0.366', 'groupId': 'OG001', 'lowerLimit': '0.285', 'upperLimit': '0.396'}]}]}, {'title': '[pyridine-D4]Hydroxy acid', 'categories': [{'measurements': [{'value': '0.150', 'groupId': 'OG000', 'lowerLimit': '0.128', 'upperLimit': '0.175'}, {'value': '0.140', 'groupId': 'OG001', 'lowerLimit': '0.120', 'upperLimit': '0.163'}]}]}, {'title': '[pyridine-D4]Hydroxy acid :[pyridine-D4]total NNAL', 'categories': [{'measurements': [{'value': '0.455', 'groupId': 'OG000', 'lowerLimit': '0.409', 'upperLimit': '0.508'}, {'value': '0.420', 'groupId': 'OG001', 'lowerLimit': '0.377', 'upperLimit': '0.469'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-13.8', 'ciUpperLimit': '-1.2', 'groupDescription': '% difference between Placebo and PEITC periods in the ratio of \\[pyridine-D4\\]Hydroxy acid : \\[pyridine-D4\\] total NNAL', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 5 days of treatment', 'description': 'The ratio of urinary \\[pyridine-D4\\]hydroxy acid : total \\[pyridine-D4\\]NNAL will be measured. This ratio is not expected to be influenced by the number of cigarettes smoked per day, or smoking topography.', 'unitOfMeasure': 'pmol/mg creatinine', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects of GSTM1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSTM1 Null', 'description': 'GSTM1 Null: gene for glutathione-S-transferase (GST) M1 (GSTM1), the homozygous deletion of the gene (GSTM1 null), leading to a lack of corresponding enzymatic activity.'}, {'id': 'OG001', 'title': 'GSTM1 Present', 'description': 'GSTM1 Present: gene for glutathione-S-transferase (GST) M1 (GSTM1), present in one or both alleles, leading to a enzymatic activity.'}], 'classes': [{'title': 'PEITC-NAC', 'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000', 'lowerLimit': '58.6', 'upperLimit': '87.6'}, {'value': '54.8', 'groupId': 'OG001', 'lowerLimit': '45.6', 'upperLimit': '65.8'}]}]}, {'title': 'Total ITC', 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000', 'lowerLimit': '46.7', 'upperLimit': '61.8'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '46.0'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Total ITC', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 5 days of PEITC treatment', 'description': 'Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTM1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.', 'unitOfMeasure': 'nmol/mg creatinine', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects of GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSTT1 Null', 'description': 'GSTT1 Null: gene for glutathione-S-transferase (GST) T1 (GSTT1), the homozygous deletion of the gene (GSTT1 null), leading to a lack of corresponding enzymatic activity.'}, {'id': 'OG001', 'title': 'GSTT1 Present', 'description': 'GSTT1 Present: gene for glutathione-S-transferase (GST) T1 (GSTT1), present in one or both alleles, leading to a enzymatic activity.'}], 'classes': [{'title': 'PEITC-NAC', 'categories': [{'measurements': [{'value': '67.1', 'groupId': 'OG000', 'lowerLimit': '50.3', 'upperLimit': '89.6'}, {'value': '60.4', 'groupId': 'OG001', 'lowerLimit': '51.5', 'upperLimit': '70.7'}]}]}, {'title': 'Total ITC', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '60.4'}, {'value': '45.1', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '50.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 5 days of treatment', 'description': 'Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTT1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.', 'unitOfMeasure': 'nmol/mg creatinine', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Combined Effects of GSTM1 and GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSTM1 and GSTT1 Both Genes Null', 'description': 'GSTM1 \\& GSTT1 Null: genes for glutathione-S-transferase (GST) M1 \\& T1, the homozygous deletion of both genes (GSTM1 null and GSTT1 null), leading to a lack of corresponding enzymatic activity.'}, {'id': 'OG001', 'title': 'GSTM1 and GSTT1 Only One Gene Present', 'description': 'GSTM1 or GSTT1 Present: at least one allele positive for either the gene for glutathione-S-transferase (GST) M1 or T1, but not or both genes, leading to moderate enzymatic activity.'}, {'id': 'OG002', 'title': 'GSTM1 and GSTT1 Both Genes Present', 'description': 'GSTM1 and GSTT1 Present: at least one allele positive for both glutathione-S-transferase (GST) M1 and T1, leading to higher enzymatic activity.'}], 'classes': [{'title': 'PEITC-NAC', 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '59.7', 'upperLimit': '122.2'}, {'value': '60.5', 'groupId': 'OG001', 'lowerLimit': '48.6', 'upperLimit': '75.3'}, {'value': '56.9', 'groupId': 'OG002', 'lowerLimit': '46.6', 'upperLimit': '69.6'}]}]}, {'title': 'Total ITC', 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000', 'lowerLimit': '46.3', 'upperLimit': '76.5'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '40.4', 'upperLimit': '55.0'}, {'value': '41.5', 'groupId': 'OG002', 'lowerLimit': '36.1', 'upperLimit': '47.8'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Total ITC', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 5 days of treatment', 'unitOfMeasure': 'nmol/mg creatinine', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urinary Levels of [Pyridine-D4]Hydroxy Acid:Total [Pyridine-D4]NNAL Ratio by GSTM1 and GSTT1 Genotype.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSTM1 and GSTT1 Both Genes Null', 'description': 'GSTM1 \\& GSTT1 Null: genes for glutathione-S-transferase (GST) M1 \\& T1, the homozygous deletion of both genes (GSTM1 null and GSTT1 null), leading to a lack of corresponding enzymatic activity.'}, {'id': 'OG001', 'title': 'GSTM1 and GSTT1 Only One Gene Present', 'description': 'GSTM1 or GSTT1 Present: at least one allele positive for either the gene for glutathione-S-transferase (GST) M1 or T1, but not or both genes, leading to moderate enzymatic activity.'}, {'id': 'OG002', 'title': 'GSTM1 and GSTT1 Both Genes Present', 'description': 'GSTM1 and GSTT1 Present: at least one allele positive for both glutathione-S-transferase (GST) M1 and T1, leading to higher enzymatic activity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.6', 'groupId': 'OG000', 'lowerLimit': '-26.7', 'upperLimit': '-2.9'}, {'value': '-3.1', 'groupId': 'OG001', 'lowerLimit': '-14.6', 'upperLimit': '9.9'}, {'value': '-9.4', 'groupId': 'OG002', 'lowerLimit': '-17.4', 'upperLimit': '-0.6'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.623', 'groupIds': ['OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.045', 'groupIds': ['OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After 5 days of treatment', 'description': '% Difference in ratio of urinary \\[pyridine-D4\\]hydroxy acid : total \\[pyridine-D4\\]NNAL while on PEITC compared to while on Placebo ((PEITC - Placebo) / PEITC) x 100%', 'unitOfMeasure': 'percentage of change in ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PEITC - Placebo (Short-term Trial)', 'description': 'Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.\n\nphenethyl isothiocyanate: Given orally\n\nplacebo: Given orally'}, {'id': 'FG001', 'title': 'Placebo - PEITC (Short-term Trial)', 'description': 'Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.\n\nphenethyl isothiocyanate: Given orally\n\nplacebo: Given orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'comment': '107 total randomized. Approximately 1/2 per arm.', 'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'comment': '45 completed, but 4 excluded b/c urinary measures indicated they did not smoke study cigarettes.', 'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PEITC - Placebo (Short-term Trial)', 'description': 'Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.\n\nphenethyl isothiocyanate: Given orally\n\nplacebo: Given orally'}, {'id': 'BG001', 'title': 'Placebo - PEITC (Short-term Trial)', 'description': 'Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.\n\nphenethyl isothiocyanate: Given orally\n\nplacebo: Given orally'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '41.0', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Level of Education', 'classes': [{'title': 'High school or lower', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'College or higher', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current smoking rate', 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '19.0', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '19.1', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cigarette smoking history', 'classes': [{'title': 'Years of smoking', 'categories': [{'measurements': [{'value': '14.7', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '17.9', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '16.3', 'spread': '9.8', 'groupId': 'BG002'}]}]}, {'title': 'Age at starting smoking', 'categories': [{'measurements': [{'value': '15.2', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '15.1', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '15.1', 'spread': '4.7', 'groupId': 'BG002'}]}]}, {'title': 'Age became regular smokers', 'categories': [{'measurements': [{'value': '18.6', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '17.7', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '18.1', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alcohol drinking', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Monthly or less', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Greater than monthly', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'GSTM1 & GSTT1 genotypes', 'classes': [{'title': 'Both present', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Present/null', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Null/present', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Both null', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2008-06-04', 'resultsFirstSubmitDate': '2017-02-14', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-14', 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Levels of Biomarkers of NNK Metabolism', 'timeFrame': '2 periods, 5 days each on PEITC or Placebo, with washout week between', 'description': 'Urinary levels of Total ITC and PEITC-NAC by treatment sequence groups and treatment period.'}, {'measure': 'Urinary Levels of Biomarkers of NNK Metabolism', 'timeFrame': 'After 5 days of treatment', 'description': 'The ratio of urinary \\[pyridine-D4\\]hydroxy acid : total \\[pyridine-D4\\]NNAL will be measured. This ratio is not expected to be influenced by the number of cigarettes smoked per day, or smoking topography.'}], 'secondaryOutcomes': [{'measure': 'Effects of GSTM1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC', 'timeFrame': 'After 5 days of PEITC treatment', 'description': 'Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTM1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.'}, {'measure': 'Effects of GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC', 'timeFrame': 'After 5 days of treatment', 'description': 'Measured by high-performance liquid chromatography (HPLC). The aim is to determine the possible differential effects of GSTT1 genotype on PEITC excretion, using the method of Chung et al. The method will result in quantitative recovery of the PEITC-NAC.'}, {'measure': 'Combined Effects of GSTM1 and GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC', 'timeFrame': 'After 5 days of treatment'}, {'measure': 'Urinary Levels of [Pyridine-D4]Hydroxy Acid:Total [Pyridine-D4]NNAL Ratio by GSTM1 and GSTT1 Genotype.', 'timeFrame': 'After 5 days of treatment', 'description': '% Difference in ratio of urinary \\[pyridine-D4\\]hydroxy acid : total \\[pyridine-D4\\]NNAL while on PEITC compared to while on Placebo ((PEITC - Placebo) / PEITC) x 100%'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'small cell lung cancer', 'tobacco use disorder'], 'conditions': ['Lung Cancer', 'Tobacco Use Disorder']}, 'referencesModule': {'references': [{'pmid': '26951845', 'type': 'RESULT', 'citation': 'Yuan JM, Stepanov I, Murphy SE, Wang R, Allen S, Jensen J, Strayer L, Adams-Haduch J, Upadhyaya P, Le C, Kurzer MS, Nelson HH, Yu MC, Hatsukami D, Hecht SS. Clinical Trial of 2-Phenethyl Isothiocyanate as an Inhibitor of Metabolic Activation of a Tobacco-Specific Lung Carcinogen in Cigarette Smokers. Cancer Prev Res (Phila). 2016 May;9(5):396-405. doi: 10.1158/1940-6207.CAPR-15-0380. Epub 2016 Mar 7.'}, {'pmid': '33989764', 'type': 'DERIVED', 'citation': 'Dinh TN, Parat MO, Ong YS, Khaw KY. Anticancer activities of dietary benzyl isothiocyanate: A comprehensive review. Pharmacol Res. 2021 Jul;169:105666. doi: 10.1016/j.phrs.2021.105666. Epub 2021 May 12.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of phenethyl isothiocyanate may prevent lung cancer in people who smoke cigarettes.\n\nPURPOSE: This randomized clinical trial is studying phenethyl isothiocyanate to see how well it works in preventing lung cancer in smokers.', 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* To determine whether oral phenethyl isothiocyanate (PEITC) affects urinary levels of biomarkers of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) metabolism in current smokers.\n\nSecondary\n\n* To determine the effect of GSTM1 genotype on PEITC's impact on urinary biomarkers of NNK metabolism.\n* To determine the effect of GSTM1 genotype on the metabolism and excretion of PEITC as measured by urinary levels of its major metabolite.\n* To determine whether oral PEITC affects molecular markers of cell proliferation (Ki-67) and apoptosis (caspase-3 and TUNEL) in bronchial tissue.\n\nOUTLINE: Patients are stratified according to GST genotypes (GSTM1 null-null genotype vs GSTM1-positive genotype). All participants are initially enrolled in the short-term trial. After the completion of the short-term trial, only those participants meeting certain criteria may proceed to the long-term trial.\n\n* Short-term trial: Participants are randomized to 1 of 2 treatment arms.\n\n * Arm I: Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.\n * Arm II: Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.\n\nAfter completion of the short-term trial, participants undergo a wash-out period for 1 month in which they are asked to resume smoking regular cigarettes. Participants are offered smoking cessation assistance, if desired. Only those participants meeting certain criteria may proceed to the long-term trial after the 1-month wash-out period.\n\n* Long-term trial: Participants are randomized to 1 of 2 treatment arms.\n\n * Arm I: Participants receive oral PEITC twice daily for 12 months.\n * Arm II: Participants receive oral placebo twice daily for 12 months. Participants in both arms complete a 3-day food diary monthly for 12 months and a food-frequency questionnaire at baseline and at the completion of study treatment.\n\nAll participants undergo blood and urine sample collection periodically for laboratory studies. Participants enrolled in the long-term trial also undergo bronchoscopy and tissue biopsy at baseline and at the completion study treatment. Urine samples are examined by liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) for various biomarkers. Tissue samples are examined by IHC for Ki-67, TUNEL, and caspase-3 expression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nInitial from phone interview:\n\n* Currently smoking 10-45 cigarettes per day for the past year;\n* Between the ages of 21 and 70 years;\n* In apparently good physical health with no unstable medical conditions including seizures or cancer;\n* In stable and good mental health, i.e., currently do not experience unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria, during the past six months;\n* Not using any other tobacco or nicotine-containing products;\n* Not on methadone maintenance or stimulants such as ephedra; not a regular user of street drugs and if uses occasionally, willing to abstain during the study; not taking any drugs known to be P4501A6 substrates such as phenobarbital, rifampicin, dexamethasone, ketoconazole, methoxsalen, pilocarpine, or tranylcypromine due to their role in NNK metabolism;\n* Does not average more than 21 alcoholic drinks per week;\n* Willing to perform study activities such as having blood sample drawn, urine collection, multiple clinic visits;\n* For female subjects of child bearing potential, not known to be pregnant or nursing, or planning to become pregnant within next 12 months.\n\nFor enrollment in the Short-Term Trial:\n\n* Subjects who are generally healthy with liver enzyme and blood count values within the ranges shown below based on blood samples drawn at the second screening visit. Specifically:\n\n * White blood cells ≥ 3,000/mL\n * Total bilirubin ≤ 1.5 x upper limits of normal (ULN)\n * AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN\n * BUN and serum creatinine ≤ 1.5 x ULN\n\nFor enrollment in the Long-Term Trial:\n\n* Participated in the short-term trial and invited to participate in the long-term trial;\n* Possess the GSTM1 null-null genotype;\n* Smoke 20 or more cigarettes/day with a cumulative smoking history of 20 or more pack-years (one pack-year equals to smoking a pack of cigarettes a day for one year);\n* Normal liver enzymes based on blood sample drawn during 1 month wash-out;\n* Determined to be a good candidate for the bronchoscopy procedure by a primary care physician.\n\nExclusion Criteria:\n\n* Subjects with uncontrolled hypertension, uncontrolled diabetes mellitus, unstable coronary artery disease, history of cancer other than non-melanoma skin cancer, and pregnant or lactating women will not be eligible.'}, 'identificationModule': {'nctId': 'NCT00691132', 'briefTitle': 'Phenethyl Isothiocyanate in Preventing Lung Cancer in Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Randomized Trial of PEITC as a Modifier of NNK Metabolism in Smokers', 'orgStudyIdInfo': {'id': '2007NT127'}, 'secondaryIdInfos': [{'id': 'R01CA122244', 'link': 'https://reporter.nih.gov/quickSearch/R01CA122244', 'type': 'NIH'}, {'id': '0712M22651', 'type': 'OTHER', 'domain': 'IRB, University of Minnesota'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEITC - Placebo (short-term trial)', 'description': 'Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.', 'interventionNames': ['Drug: phenethyl isothiocyanate', 'Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo - PEITC (short-term trial)', 'description': 'Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.', 'interventionNames': ['Drug: phenethyl isothiocyanate', 'Other: placebo']}], 'interventions': [{'name': 'phenethyl isothiocyanate', 'type': 'DRUG', 'otherNames': ['PEITC'], 'description': 'Given orally', 'armGroupLabels': ['PEITC - Placebo (short-term trial)', 'Placebo - PEITC (short-term trial)']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Given orally', 'armGroupLabels': ['PEITC - Placebo (short-term trial)', 'Placebo - PEITC (short-term trial)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Dorothy K. Hatsukami, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}