Phase II Randomized, Double Blind, Placebo-Controlled Trial of Broccoli Seed and Sprout Extract (BSSE), Avmacol ES, to Evaluate Sustained Detoxification of Tobacco Carcinogens in Heavy Smokers
National Cancer Institute (NCI)
Summary
This phase II trial tests whether broccoli seed and sprout extract works to break down cancer causing substances of tobacco in heavy smokers. Smokers are at increased risk for developing lung, head and neck, and other cancers. Broccoli seed and sprout extract may help break down and remove toxic substances caused by tobacco use and possibly produce substances that may protect cells from tobacco smoke-induced damage in current smokers.
Description
PRIMARY OBJECTIVE: I. To determine whether broccoli sprout/broccoli seed extract supplement (broccoli seed and sprout extract \[BSSE\]) sustainably increases the urinary excretion of the mercapturic acids of the tobacco carcinogens benzene and/or acrolein over a 12-week exposure period in otherwise healthy, current smokers. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of BSSE over a 12-week exposure period. II. To evaluate whether BSSE sustainably increases the urinary excretion of the mercapturic acid of the tobacco carcinogen crotonaldehyde. III. To evaluate the bioa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Male or female current tobacco smokers with \>= 20 pack years of self-reported smoking exposure and a current average use of \>= 10 cigarettes/day * Age \>= 18 years. No upper age limit * Karnofsky performance scale \>= 70% * Absolute neutrophil count \>= 1,000/microliter * Platelets \>= 100,000/microliter * Total bilirubin =\< 2 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x ULN * Creatinine =\< 1.5 x…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood, buccal cell, and nasal epithelial cell samples
- Dietary SupplementBroccoli Sprout/Broccoli Seed Extract Supplement
Given PO
- DrugPlacebo Administration
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Locations (3)
- University of Arizona Cancer Center - Prevention Research ClinicTucson, Arizona
- George Washington University Medical CenterWashington D.C., District of Columbia
- Roswell Park Cancer InstituteBuffalo, New York