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

NCT05121051 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Cigarette Smoking-Related Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood, buccal cell, and nasal epithelial cell samples

DIETARY_SUPPLEMENT

Broccoli Sprout/Broccoli Seed Extract Supplement

Given PO

DRUG

Placebo Administration

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Julie E Bauman · George Washington University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2027-01-13
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05121051 on ClinicalTrials.gov