Cigarette Smoking-Related CarcinomaPhase 2NCT05121051
Testing the Effect of the Broccoli Seed and Sprout Extract, Avmacol ES, on the Cancer Causing Substances of Tobacco in Heavy Smokers
A Phase 2 study testing Biospecimen Collection, Broccoli Sprout/Broccoli Seed Extract Supplement and Questionnaire Administration in people with Cigarette Smoking-Related Carcinoma, run by National Cancer Institute (NCI) at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Biospecimen Collection, Broccoli Sprout/Broccoli Seed Extract Supplement and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Sep 2022to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Mary E. Reid, 716-845-1209, mary.reid@roswellpark.org
Mary E. Reid
- Recruiting
University of Arizona Cancer Center - Prevention Research Clinic
Tucson, Arizona, 85719
Linda L. Garland, 202-994-0329
Linda L. Garland
- Recruiting
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Julie E. Bauman, 202-994-0329, jebauman@gwu.edu
Julie E. Bauman
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Biospecimen Collection, Broccoli Sprout/Broccoli Seed Extract Supplement, Placebo Administration, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood, buccal cell, and nasal epithelial cell samples
Broccoli Sprout/Broccoli Seed Extract SupplementDietary supplement
Also called Avmacol
Given PO
Placebo AdministrationDrug
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detoxification of benzene and acrolein
Measured by changes in the urinary levels of their respective mercapturic acids, SPMA and 3-HPMA, from baseline.
Measured: At baseline and 2, 4, 8, and 12 weeks
Secondary outcomes (5)
Incidence of adverse events (AE)s
Measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 5. The frequency and associated percentage of each specific AE will be tabulated by the treatment group and then compared via Fisher's exact test. The tolerability will be measured by the adherence rate and will be compared between the broccoli seed and sprout extract (BSSE) and placebo groups via Fisher's exact test.
Measured: Up to 12 weeks
Increases in detoxification of crotonaldehyde
Will determine whether BSSE sustainably increases the detoxification of crotonaldehyde, as measured by changes in the creatinine-normalized urinary levels of its mercapturic acid metabolite, 3-HMPMA, over time. Similar to the carcinogens, benzene and acrolein, the detoxification of crotonaldehyde will be measured by change at 2 weeks, 4 weeks, 8 weeks and 12 weeks in the urinary excretion of 3-HMPMA from baseline, and a linear mixed effects model will be fit to changes in log-transformed urinary 3-HMPMA levels from baseline.
Measured: At baseline and 2, 4, 8, and 12 weeks
Bioavailability of BSSE
Measured by urinary sulforaphane (SF) metabolites.
Measured: At baseline and 2, 4, 8, and 12 weeks
Dose-response relationship between effective SF dose and the detoxification of benzene and acrolein
A dose-response relationship between SF metabolites and detoxification of benzene and/or acrolein will be assessed by a linear mixed effects model with random intercepts, in which changes from baseline in each of the log-transformed urinary mercapturic acid levels as the dependent variable (response) and changes from baseline in SF metabolites as the independent variable (dose).
Measured: Baseline up to 12 weeks
Genetic modulators of detoxification of tobacco carcinogens
Will assess whether the GSTM1 and GSTT1 genotypes are important genetic modulators of detoxification of tobacco carcinogens in the setting of prolonged exposure to BSSE. The association of GSTM1 and GSTT1 genotypes with detoxification of benzene and/or acrolein will be assessed by a linear mixed effects model with random intercepts for changes from baseline in each of the log transformed mercapturic acid levels, in which the fixed effects include BSSE, genotype and time indicators and two-way and three-way interactions of BSSE, genotype and time indicators. This will allow us to study whether 1) the BSSE effect if significant is modulated by the genotypes, 2) the time effect if significant is modulated by the genotypes, or 3) the interaction effect between BSSE and time if significant is modulated by the genotypes.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start21 Sep 2022
- Primary completion13 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Julie E Bauman, Principal investigator, George Washington University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121051
- Sponsor's protocol ID
- NCI-2021-12014
- Other IDs
- NCI-2021-12014, STUDY00000614, UAZ21-06-01, P30CA023074, UG1CA242596
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2021
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.