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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Randomized Study of Phenethyl Isothiocyanate as a Modifier of NNK Metabolism in Smokers

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Biomarker/Laboratory analysis, Prevention Approved-not yet active 21 to 70 NCI UMN-2007NT127 PEITC, NCT00691132

Trial Description

Purpose:

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.

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

Eligibility:

Eligibility criteria include the following:

• 21-70 years old
• Has smoked 10 to 45 light or ultralight cigarettes each day for the past year
• Not using any other tobacco or nicotine -containing products
• Not currently taking acetaminophen, phenacetin, tamoxifen, bupropion, or theophylline
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Participants in group one will be asked to smoke only the cigarettes provided by the study and record the exact number of cigarettes smoked each day for 4 weeks. They will receive phenethyl isothiocyanate by mouth four times a day for 5 days in week 2 and a placebo by mouth four times a day for 5 days in week 4. Participants will also keep a food diary on the days that phenethyl isothiocyanate or a placebo are taken.

Participants in group two will be asked to smoke only the cigarettes provided by the study and record the exact number of cigarettes smoked each day for 4 weeks. They will receive a placebo by mouth four times a day for 5 days in week 2 and phenethyl isothiocyanate by mouth four times a day for 5 days in week 4. Participants will also keep a food diary on the days that phenethyl isothiocyanate or a placebo are taken.

After finishing treatment, participants in both groups will be asked to start smoking their usual cigarettes for 1 month. They will also be offered assistance to stop smoking. After 1 month, some participants will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Participants in group one will receive phenethyl isothiocyanate by mouth twice a day for 1 year. They will also fill out a 3-day food diary once a month for 1 year and a food-frequency questionnaire at the beginning of the study and after finishing treatment.

Participants in group two will receive a placebo by mouth twice a day for 1 year. They will also fill out a 3-day food diary once a month for 1 year and a food-frequency questionnaire at the beginning of the study and after finishing treatment.

All participants will undergo blood and urine sample collection periodically for laboratory studies. Some participants will also undergo bronchoscopy and tissue biopsy at the beginning of the study and after finishing treatment.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Masonic Cancer Center at University of Minnesota

Jian-Min Yuan, PhD, Principal investigator		Ph: 612-625-8056; 888-226-2376

Registry Information
Official Title		Randomized Trial of PEITC as a Modifier of NNK Metabolism in Smokers
Trial Start Date		2008-06-01 (estimated)
Trial Completion Date		2013-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00691132
Date Submitted to PDQ		2008-05-16
Information Last Verified		2008-12-28
NCI Grant/Contract Number		CA122244, CA77598