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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05121051
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood, buccal cell, and nasal epithelial cell samples
  • Broccoli Sprout/Broccoli Seed Extract Supplement — DIETARY_SUPPLEMENT
    Given PO
  • Placebo Administration — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Sep 21, 2022
Status verified
Jan 2026
Primary completion
Jan 13, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Locations (3)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center - Prevention Research ClinicTucsonArizona85719
Linda L. Garland
202-994-0329
Linda L. Garland (PRINCIPAL_INVESTIGATOR)
George Washington University Medical CenterWashington D.C.District of Columbia20037
Julie E. Bauman
[email protected]
202-994-0329
Julie E. Bauman (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer InstituteBuffaloNew York14263
Mary E. Reid
[email protected]
716-845-1209
Mary E. Reid (PRINCIPAL_INVESTIGATOR)

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By research site
University of Arizona Cancer Center - Prevention Research Clinic· Tucson, AZGeorge Washington University Medical Center· Washington D.C., DCRoswell Park Cancer Institute· Buffalo, NY

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