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

NCT05121051 | Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: NCI-2021-12014STUDY00000614UAZ21-06-01P30CA023074UG1CA242596
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• Detoxification of benzene and acrolein

  Measured by changes in the urinary levels of their respective mercapturic acids, SPMA and 3-HPMA, from baseline.

  At baseline and 2, 4, 8, and 12 weeks

Secondary Outcomes (5)

• Incidence of adverse events (AE)s

  Up to 12 weeks

• Increases in detoxification of crotonaldehyde

  At baseline and 2, 4, 8, and 12 weeks

• Bioavailability of BSSE

  At baseline and 2, 4, 8, and 12 weeks

• Dose-response relationship between effective SF dose and the detoxification of benzene and acrolein

  Baseline up to 12 weeks

• Genetic modulators of detoxification of tobacco carcinogens

  Up to 12 weeks

Other Outcomes (2)

• Change in mucosal signatures of NRF2 activation, inflammation, and innate immunity

  Baseline up to 12 weeks

• Modulation of nasal epithelial gene signatures

  Up to 12 weeks

Study Arms (2)

Group I (broccoli seed and sprout extract)

EXPERIMENTAL

Patients receive broccoli seed and sprout extract 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.

Procedure: Biospecimen Collection; Dietary Supplement: Broccoli Sprout/Broccoli Seed Extract Supplement; Other: Questionnaire Administration

Group II (placebo)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Ancillary studies

Group I (broccoli seed and sprout extract); Group II (placebo)

Broccoli Sprout/Broccoli Seed Extract Supplement DIETARY_SUPPLEMENT

Given PO

Also known as: Avmacol

Group I (broccoli seed and sprout extract)

Biospecimen Collection PROCEDURE

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

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group I (broccoli seed and sprout extract); Group II (placebo)

Placebo Administration DRUG

Given PO

Group II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Platelets \>= 100,000/microliter
• Total bilirubin =\< 2 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x ULN
• Creatinine =\< 1.5 x ULN
• Participants with known human immunodeficiency virus (HIV) infection are not eligible for this trial due to potential interaction between sulforaphane and anti-retroviral therapy
• Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment are not eligible due to potential interaction between sulforaphane and anti-retroviral therapy
• The effects of BSSE on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• 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
• Participants may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Avmacol ES® (BSSE)
• Uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• Any other condition or lifestyle factor, that, in the opinion of the principal investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
• Pregnant or lactating women. Pregnant women are excluded from this study because the effects of BSSE on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with BSSE, Breastfeeding should be discontinued if the mother is treated with BSSE

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

University of Arizona Cancer Center - Prevention Research Clinic

Tucson, Arizona, 85719, United States

RECRUITING

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Julie E Bauman

  George Washington University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: November 16, 2021
• Study Start: September 21, 2022
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)