Status:
COMPLETED
Phenethyl Isothiocyanate in Preventing Lung Cancer in Smokers
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Tobacco Use Disorder
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
Brief Summary
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. PURPOSE: This randomize...
Detailed Description
OBJECTIVES: Primary * To determine whether oral phenethyl isothiocyanate (PEITC) affects urinary levels of biomarkers of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) metabolism in current sm...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Initial from phone interview:
- Currently smoking 10-45 cigarettes per day for the past year;
- Between the ages of 21 and 70 years;
- In apparently good physical health with no unstable medical conditions including seizures or cancer;
- 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;
- Not using any other tobacco or nicotine-containing products;
- 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;
- Does not average more than 21 alcoholic drinks per week;
- Willing to perform study activities such as having blood sample drawn, urine collection, multiple clinic visits;
- For female subjects of child bearing potential, not known to be pregnant or nursing, or planning to become pregnant within next 12 months.
- For enrollment in the Short-Term Trial:
- 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:
- White blood cells ≥ 3,000/mL
- Total bilirubin ≤ 1.5 x upper limits of normal (ULN)
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN
- BUN and serum creatinine ≤ 1.5 x ULN
- For enrollment in the Long-Term Trial:
- Participated in the short-term trial and invited to participate in the long-term trial;
- Possess the GSTM1 null-null genotype;
- 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);
- Normal liver enzymes based on blood sample drawn during 1 month wash-out;
- Determined to be a good candidate for the bronchoscopy procedure by a primary care physician.
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00691132
Start Date
February 1 2009
End Date
January 1 2013
Last Update
May 12 2017
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455