Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT05121051

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

135

Participants Needed

3

Research Sites

275 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female current tobacco smokers with �3E= 20 pack years of self-reported smoking exposure and a current average use of �3E= 10 cigarettes/day
  • Age �3E= 18 years. No upper age limit
  • Karnofsky performance scale �3E= 70%
  • Absolute neutrophil count �3E= 1,000/microliter
  • Platelets �3E= 100,000/microliter
  • Total bilirubin �3C= 2 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) �3C= 3 x ULN
  • Creatinine �3C= 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
  • 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
  • Ability to understand and the willingness to sign a written informed consent document
Not Eligible

You will not qualify if you...

  • 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
  • Participants must agree to stop glucoraphanin or sulforaphane products at least 7 days before baseline visit
  • Participants with known chronic hepatitis B virus (HBV) infection are excluded
  • Participants may not be receiving any other investigational agents
  • History of allergic reactions to compounds similar to Avmacol ES (BSSE)
  • Uncontrolled serious illness including infection, congestive heart failure, unstable angina, or cardiac arrhythmia
  • Any condition or lifestyle factor that may affect ability to complete study or pose risk
  • Pregnant or lactating women are excluded due to unknown effects of BSSE on fetus and nursing infants

AI-Screening

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Trial Site Locations

Total: 3 locations

1

University of Arizona Cancer Center - Prevention Research Clinic

Tucson, Arizona, United States, 85719

Actively Recruiting

2

George Washington University Medical Center

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

Actively Recruiting

3

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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