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.
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
History of invasive cancer within the past 2 years, except for excised and cured non-melanoma skin cancer or carcinoma in situ of the cervix. Participants who continue adjuvant treatment for an index cancer occurring > 2 years ago, such as adjuvant hormonal therapy for breast cancer, are excluded. Participants who are on anti-neoplastic treatment for a chronic malignancy, such as multiple myeloma or chronic myelogenous leukemia, are excluded
Ongoing use of a nutraceutical or dietary supplement containing glucoraphanin or sulforaphane
Note, participants will be eligible if they agree to stop the glucoraphanin or sulforaphane product at least 7 days prior to the baseline visit (7-day washout)
Participants with known chronic hepatitis B virus (HBV) infection are not eligible for this trial due to potential interaction between sulforaphane and suppressive anti-viral therapy
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood, buccal cell, and nasal epithelial cell samples
Broccoli Sprout/Broccoli Seed Extract Supplement
Dietary supplementGiven PO
Placebo Administration
DrugGiven PO
Questionnaire Administration
Other interventionAncillary studies
Detoxification of benzene and acrolein
Measured by changes in the urinary levels of their respective mercapturic acids, SPMA and 3-HPMA, from baseline.
Incidence of adverse events (AE)s
Measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 5. The frequency and associated percentage of each specific AE will be tabulated by the treatment group and then compared via Fisher's exact test. The tolerability will be measured by the adherence rate and will be compared between the broccoli seed and sprout extract (BSSE) and placebo groups via Fisher's exact test.
Increases in detoxification of crotonaldehyde
Will determine whether BSSE sustainably increases the detoxification of crotonaldehyde, as measured by changes in the creatinine-normalized urinary levels of its mercapturic acid metabolite, 3-HMPMA, over time. Similar to the carcinogens, benzene and acrolein, the detoxification of crotonaldehyde will be measured by change at 2 weeks, 4 weeks, 8 weeks and 12 weeks in the urinary excretion of 3-HMPMA from baseline, and a linear mixed effects model will be fit to changes in log-transformed urinary 3-HMPMA levels from baseline.
Bioavailability of BSSE
Measured by urinary sulforaphane (SF) metabolites.
Dose-response relationship between effective SF dose and the detoxification of benzene and acrolein
A dose-response relationship between SF metabolites and detoxification of benzene and/or acrolein will be assessed by a linear mixed effects model with random intercepts, in which changes from baseline in each of the log-transformed urinary mercapturic acid levels as the dependent variable (response) and changes from baseline in SF metabolites as the independent variable (dose).
Change in mucosal signatures of NRF2 activation, inflammation, and innate immunity
Measured by the NanoString nCounter® PanCancer panel.
Modulation of nasal epithelial gene signatures
Will assess modulation of nasal epithelial gene signatures including smoking, lung cancer, and squamous dysplasia.
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