Recruiting
Phase 2

Broccoli Extract

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05121051

Conditions

Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Broccoli Sprout/Broccoli Seed Extract Supplement

Placebo Administration

Questionnaire Administration

Study Details

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

Study ID

NCT05121051

Start date

Sep 21, 2022

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jan 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group I (broccoli seed and sprout extract)

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.

active comparator: Group II (placebo)

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.

Interventions

Biospecimen Collection

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

Broccoli Sprout/Broccoli Seed Extract Supplement

Given PO

Placebo Administration

Given PO

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Detoxification of benzene and acrolein [ Time Frame: At baseline and 2, 4, 8, and 12 weeks ]

Central Contacts and Locations

Locations

University of Arizona Cancer Center - Prevention Research Clinic

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Linda L. Garland

202-994-0329

Principal Investigator:

Linda L. Garland

George Washington University Medical Center

Recruiting

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

Contacts

Julie E. Bauman

202-994-0329jebauman@gwu.edu

Principal Investigator:

Julie E. Bauman

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Mary E. Reid

716-845-1209mary.reid@roswellpark.org

Principal Investigator:

Mary E. Reid

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-07-14.