Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 1:54 PM
Study NCT ID:
NCT05121051
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Effect of the Broccoli Seed and Sprout Extract, Avmacol ES, on the Cancer Causing Substances of Tobacco in Heavy Smokers
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Randomized, Double Blind, Placebo-Controlled Trial of Broccoli Seed and Sprout Extract (BSSE), Avmacol ES, to Evaluate Sustained Detoxification of Tobacco Carcinogens in Heavy Smokers
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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. Patients undergo the collection of blood, nasal epithelial cell, and buccal cell samples throughout the study.
GROUP II: Patients receive placebo PO QD for 12 weeks in the absence of unacceptable toxicity. Patients undergo the collection of blood, nasal epithelial cell, and buccal cell samples throughout the study.
After completion of study, patients are followed up at 2-4 weeks.
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. Patients undergo the collection of blood, nasal epithelial cell, and buccal cell samples throughout the study.
GROUP II: Patients receive placebo PO QD for 12 weeks in the absence of unacceptable toxicity. Patients undergo the collection of blood, nasal epithelial cell, and buccal cell samples throughout the study.
After completion of study, patients are followed up at 2-4 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-12014 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STUDY00000614 | OTHER | University of Arizona Cancer Center - Prevention Research Clinic | View | |
| UAZ21-06-01 | OTHER | DCP | View | |
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |
| UG1CA242596 | NIH | None | https://reporter.nih.gov/quic… | View |