NCT03402230

Broccoli Sprout/Broccoli Seed Extract Supplement in Decreasing Toxicity in Heavy Smokers

Clinical Study of Avmacol® for Detoxification of Tobacco Carcinogens in Heavy Smokers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This randomized early phase I trial studies how well broccoli sprout/broccoli seed extract supplement works in decreasing toxicity in heavy smokers. Broccoli sprout/broccoli seed extract supplement is a dietary supplement made from broccoli sprout and seed extract powder, and may break down some of the cancer causing substances in tobacco smoke and produce substances that may protect cells from tobacco smoke-induced damage in current smokers.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether broccoli sprout/broccoli seed extract supplement (Avmacol) increases the urinary excretion of the mercapturic acid of the tobacco carcinogen, benzene, in healthy volunteers who are current heavy smokers. SECONDARY OBJECTIVES: I. To determine whether Avmacol increases the urinary excretion of the mercapturic acids of other tobacco carcinogens, including acrolein and crotonaldehyde. II. To determine whether Avmacol increases the urinary excretion of the mercapturic acids of tobacco carcinogens, normalized by bio-measurement of tobacco exposure. III. To determine whether Avmacol upregulates the NRF2 target gene transcripts in the buccal cells of current smokers. IV. To evaluate for a dose-response relationship between Avmacol and the detoxification of tobacco carcinogens and the expression of NRF2 target gene transcripts. V. To determine the relationship between systemic study agent exposure and biomarker modulation. EXPLORATORY OBJECTIVES: I. To determine whether the GSTM1 and GSTT1 genotypes are important genetic modulators of detoxification of tobacco carcinogens with Avmacol treatment. II. To bank specimens for future research including evaluation of tobacco gene signatures in buccal and nasal epithelium and buccal cell nuclear morphometry. OUTLINE: Participants are randomized into 1 of 2 arms. ARM I: Participants receive lower dose broccoli sprout/broccoli seed extract supplement orally (PO) daily for 10-14 days. After 10-14 days, participants receive higher dose broccoli sprout/broccoli seed extract supplement PO daily for 10-14 days. ARM II: Participants receive higher dose broccoli sprout/broccoli seed extract supplement PO daily for 10-14 days. After 10-14 days, participants receive lower dose broccoli sprout/broccoli seed extract supplement PO daily for 10-14 days. After completion of study, participants are followed up at 10-14 days.

Conditions

• Cigarette Smoking-Related Carcinoma
• Tobacco-Related Carcinoma

Interventions

Type	Name	Description
DRUG	Broccoli Sprout/Broccoli Seed Extract Supplement	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-02-20
• Primary completion: 2020-01-10
• Completion: 2022-07-24
• First posted: 2018-01-18
• Last updated: 2023-06-28
• Results posted: 2021-04-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study