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Phytochemical

Broccoli Extract for Tobacco-Related Cancer Risk

Phase 2
Recruiting
Led By Julie E Bauman
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 2, 4, 8, and 12 weeks
Awards & highlights

Study Summary

This trial is testing whether broccoli seed and sprout extract can help break down and remove the harmful toxins in tobacco smoke, and if it can help protect cells from damage caused by tobacco smoke.

Who is the study for?
This trial is for adult heavy smokers with a significant smoking history who are generally healthy. They must have normal blood counts, liver and kidney function, and if HIV or hepatitis positive, they need controlled viral loads. Women of childbearing age and men must use birth control during the study.Check my eligibility
What is being tested?
The trial is testing Avmacol ES (broccoli seed/sprout extract) to see if it helps break down harmful substances from tobacco in heavy smokers. Participants will either receive this supplement or a placebo while their biospecimens are collected for analysis.See study design
What are the potential side effects?
Potential side effects aren't detailed but could include reactions similar to those allergic to compounds like Avmacol ES. Since its effect on fetuses is unknown, pregnant women can't participate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My hepatitis B virus load is undetectable with treatment.
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I have smoked at least 20 pack-years and currently smoke 10 or more cigarettes a day.
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I am able to care for myself but may not be able to do active work.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 2, 4, 8, and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 2, 4, 8, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detoxification of benzene and acrolein
Secondary outcome measures
Bioavailability of BSSE
Dose-response relationship between effective SF dose and the detoxification of benzene and acrolein
Genetic modulators of detoxification of tobacco carcinogens
+2 more
Other outcome measures
Inflammation
Modulation of nasal epithelial gene signatures

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (broccoli seed and sprout extract)Experimental Treatment3 Interventions
Patients receive broccoli seed and sprout extract PO QD for 12 weeks in the absence of unacceptable toxicity. Patients undergo the collection of blood and nasal epithelial cell samples at visits 2 and 6 and the collection of buccal cell samples at visits 2, 3, and 6.
Group II: Group II (placebo)Active Control3 Interventions
Patients receive placebo PO QD for 12 weeks in the absence of unacceptable toxicity. Patients undergo the collection of blood and nasal epithelial cell samples at visits 2 and 6 and the collection of buccal cell samples at visits 2, 3, and 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Broccoli Sprout/Broccoli Seed Extract Supplement
2018
Completed Early Phase 1
~50

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,033 Total Patients Enrolled
Julie E BaumanPrincipal InvestigatorGeorge Washington University Cancer Center
2 Previous Clinical Trials
86 Total Patients Enrolled

Media Library

Broccoli Sprout/Broccoli Seed Extract Supplement (Phytochemical) Clinical Trial Eligibility Overview. Trial Name: NCT05121051 — Phase 2
Cancer Research Study Groups: Group I (broccoli seed and sprout extract), Group II (placebo)
Cancer Clinical Trial 2023: Broccoli Sprout/Broccoli Seed Extract Supplement Highlights & Side Effects. Trial Name: NCT05121051 — Phase 2
Broccoli Sprout/Broccoli Seed Extract Supplement (Phytochemical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05121051 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct places is this scientific inquiry being administered?

"This experiment is being conducted in University of British Columbia Hospital (Vancouver, BC), University of Arizona Cancer Center - Prevention Research Clinic (Tucson, AZ), Roswell Park Cancer Institute (Buffalo, NY) as well as other locations."

Answered by AI

Can people still sign up for the clinical trial?

"According to the clinicaltrials.gov website, this trial is not recruiting patients at this time. This study was posted on 1/30/2023 and was last edited on 8/10/2022. Although this study is not currently looking for participants, there are 11 other studies that are actively enrolling patients."

Answered by AI

Does the FDA consider broccoli supplements to be safe?

"While there is some evidence that this broccoli-based supplement is safe, its efficacy has not yet been proven. Consequently, it received a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
University of British Columbia Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Testing the Effect of the Broccoli Seed and Sprout Extract, Avmacol ES, on the Cancer Causing Substances of Tobacco in Heavy Smokers
2022. "Testing the Effect of the Broccoli Seed and Sprout Extract, Avmacol ES, on the Cancer Causing Substances of Tobacco in Heavy Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05121051.
~21 spots leftby Aug 2024
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