Testing the Effect of the Broccoli Seed and Sprout Extract, Avmacol ES, on the Cancer Causing Substances of Tobacco in Heavy Smokers

Inclusion Criteria:

• Male or female current tobacco smokers with >= 20 pack years of self-reportedsmoking 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 ULN

• Participants with known human immunodeficiency virus (HIV) infection are noteligible for this trial due to potential interaction between sulforaphane andanti-retroviral therapy

• Participants with a history of hepatitis C virus (HCV) infection must have beentreated and cured. Participants with HCV infection who are currently on treatmentare not eligible due to potential interaction between sulforaphane andanti-retroviral therapy

• The effects of BSSE on the developing human fetus at the recommended therapeuticdose are unknown. For this reason,, women of child-bearing potential and men mustagree to use adequate contraception (hormonal or barrier method of birth control;abstinence) prior to study entry and for the duration of study participation. Shoulda woman become pregnant or suspect she is pregnant while participating in thisstudy, she should inform her study physician immediately

• Ability to understand and the willingness to sign a written informed consentdocument

Exclusion Criteria:

• History of invasive cancer within the past 2 years, except for excised and curednon-melanoma skin cancer or carcinoma in situ of the cervix. Participants whocontinue adjuvant treatment for an index cancer occurring > 2 years ago, such asadjuvant hormonal therapy for breast cancer, are excluded. Participants who are onanti-neoplastic treatment for a chronic malignancy, such as multiple myeloma orchronic myelogenous leukemia, are excluded

• Ongoing use of a nutraceutical or dietary supplement containing glucoraphanin orsulforaphane

• Note, participants will be eligible if they agree to stop the glucoraphanin orsulforaphane product at least 7 days prior to the baseline visit (7-daywashout)

• Participants with known chronic hepatitis B virus (HBV) infection are not eligiblefor this trial due to potential interaction between sulforaphane and suppressiveanti-viral therapy

• Participants may not be receiving any other investigational agents

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to Avmacol ES (BSSE)

• Uncontrolled intercurrent illness including, but not limited to, serious ongoing oractive infection, symptomatic congestive heart failure, unstable angina pectoris, orcardiac arrhythmia

• Any other condition or lifestyle factor, that, in the opinion of the principalinvestigator, may adversely affect the participant's ability to complete the studyor its measures or pose significant risk to the participant

• Pregnant or lactating women. Pregnant women are excluded from this study because theeffects of BSSE on the developing human fetus are unknown. Because there is anunknown but potential risk for adverse events (AEs) in nursing infants secondary totreatment of the mother with BSSE, Breastfeeding should be discontinued if themother is treated with BSSE