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Clinical Trial 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.


Clinical Trial 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 bioavailability of BSSE measured as sulforaphane (SF) metabolites and assess for a dose-response relationship between the effective SF dose delivered by BSSE and the detoxification of benzene and acrolein. IV. To determine whether the GSTM1 and GSTT1 genotypes are important genetic modulators of detoxification of tobacco carcinogens in the setting of prolonged exposure to BSSE. EXPLORATORY OBJECTIVES: I. To evaluate modulation of mucosal signatures of nuclear factor-erythroid factor 2-related factor 2 (NRF2) activation, inflammation, and innate immunity. II. To evaluate modulation of nasal epithelial gene signatures including smoking, lung cancer, and squamous dysplasia. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive broccoli seed and sprout extract orally (PO) once daily (QD) for 12 weeks in the absence of unacceptable toxicity. GROUP II: Patients receive placebo PO QD for 12 weeks in the absence of unacceptable toxicity. After completion of study, patients are followed up at 2-4 weeks. ;


Study Design


Related Conditions & MeSH terms

  • Cigarette Smoking-Related Carcinoma

NCT number NCT05121051
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Not yet recruiting
Phase Phase 2
Start date April 24, 2022
Completion date July 31, 2024

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