Phase 2 N=107 Randomized Double-blind Prevention

Phenethyl Isothiocyanate in Preventing Lung Cancer in Smokers

Lung Cancer · Tobacco Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00691132 ↗

Enrolled (actual)

107

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Urinary Levels of Biomarkers of NNK Metabolism — 42.8; 0.36; 0.28; 49.7 pmol/mg creatinine

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: phenethyl isothiocyanate (Drug); placebo (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Urinary Levels of Biomarkers of NNK Metabolism	0.366; 0.366; 0.150; 0.140; 0.455; 0.420	0.023 sig
PRIMARY Urinary Levels of Biomarkers of NNK Metabolism	0.366; 0.366; 0.150; 0.140; 0.455; 0.420	0.023 sig
SECONDARY Effects of GSTM1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC	71.7; 54.8; 53.7; 40.5	0.005 sig
SECONDARY Effects of GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC	67.1; 60.4; 49.2; 45.1	—
SECONDARY Combined Effects of GSTM1 and GSTT1 Genotype on Phenethyl Isothiocyanate (PEITC)-NNK Association and on the Metabolism and Excretion of PEITC	85.4; 60.5; 56.9; 59.6; 47.1; 41.5	0.017 sig
SECONDARY Urinary Levels of [Pyridine-D4]Hydroxy Acid:Total [Pyridine-D4]NNAL Ratio by GSTM1 and GSTT1 Genotype.	-15.6; -3.1; -9.4	0.039 sig

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 randomized clinical trial is studying phenethyl isothiocyanate to see how well it works in preventing lung cancer in smokers.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00691132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.