120 Participants Needed

Broccoli Extract for Tobacco-Related Cancer Risk

Recruiting at 3 trial locations
MC
Overseen ByMartin C. Mahoney
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if an extract from broccoli seeds and sprouts can help heavy smokers by removing harmful substances from their bodies and protecting their cells from damage. Sulforaphane, derived from broccoli seeds and sprouts, has been shown to induce detoxification enzymes and protect against cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop using any supplements containing glucoraphanin or sulforaphane at least 7 days before starting the trial.

Is broccoli extract safe for human use?

Broccoli sprout extracts, including those rich in glucoraphanin and sulforaphane, have been studied in humans and found to be generally safe with no significant adverse effects reported. Clinical trials have shown that these extracts are well-tolerated, with no consistent toxicities observed in participants.12345

How does the broccoli extract treatment differ from other treatments for tobacco-related cancer risk?

The broccoli extract treatment is unique because it uses natural compounds from broccoli sprouts and seeds, specifically glucoraphanin and sulforaphane, to help detoxify harmful substances found in tobacco smoke. Unlike traditional treatments, it focuses on enhancing the body's natural detoxification processes to reduce cancer risk.13567

What data supports the effectiveness of the treatment Broccoli Sprout/Broccoli Seed Extract Supplement, Avmacol ES, Broccoli Seed and Sprout Extract, BSSE for reducing tobacco-related cancer risk?

Research shows that broccoli and its extracts, like sulforaphane, can help detoxify harmful substances found in tobacco smoke and reduce DNA damage in smokers. This suggests that the treatment may lower cancer risk by enhancing the body's ability to repair and protect against damage.258910

Who Is on the Research Team?

Julie E. Bauman, MD, MPH ...

Julie Bauman, MD

Principal Investigator

George Washington University Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Absolute neutrophil count >= 1,000/microliter
Ability to understand and the willingness to sign a written informed consent document
I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
See 9 more

Exclusion Criteria

I haven't taken high doses of steroids recently, except for inhalers, nasal sprays, or small area creams.
I haven't had invasive cancer, except for certain skin cancers or cervical pre-cancers, in the last 2 years.
I am not pregnant or breastfeeding.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive broccoli seed and sprout extract or placebo orally once daily for 12 weeks. Blood, nasal epithelial cell, and buccal cell samples are collected throughout the study.

12 weeks
Visits at baseline, 2, 4, 8, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Broccoli Sprout/Broccoli Seed Extract Supplement
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (broccoli seed and sprout extract)Experimental Treatment3 Interventions
Group II: Group II (placebo)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study involving 20 young males (10 smokers and 10 nonsmokers), consuming 200 grams of broccoli significantly reduced DNA damage in both groups, with a notable 22.2% decrease in strand breaks (P < 0.0001).
Broccoli intake specifically led to a 51.0% reduction in oxidized purines in smokers (P < 0.0001), highlighting its protective effects against DNA damage, although it did not affect histone deacetylase (HDAC) activity or insulin-like growth factor-I (IGF-I) levels.
Effect of broccoli intake on markers related to oxidative stress and cancer risk in healthy smokers and nonsmokers.Riso, P., Martini, D., Visioli, F., et al.[2015]
A randomized, crossover trial with 49 healthy smokers showed that broccoli seed and sprout extracts (BSSE) significantly increased the detoxification of tobacco-related carcinogens like benzene, acrolein, and crotonaldehyde, particularly at a higher dose of glucoraphanin.
The higher-dose BSSE led to a significant increase in the urinary excretion of mercapturic acids associated with these carcinogens, indicating enhanced detoxification, regardless of the participants' GST genotype.
Randomized Crossover Trial Evaluating Detoxification of Tobacco Carcinogens by Broccoli Seed and Sprout Extract in Current Smokers.Bauman, JE., Hsu, CH., Centuori, S., et al.[2023]
Broccoli consumption, particularly due to the isothiocyanate sulforaphane derived from its precursor glucoraphanin, has been linked to health benefits, including cancer chemoprotection, supported by over 3000 studies and more than 50 clinical trials.
There is a need for improved integration of animal and human studies to better understand the effective doses and mechanisms of action of sulforaphane, as well as to develop reliable biomarkers for its effects in humans.
Broccoli or Sulforaphane: Is It the Source or Dose That Matters?Yagishita, Y., Fahey, JW., Dinkova-Kostova, AT., et al.[2021]

Citations

Effect of broccoli intake on markers related to oxidative stress and cancer risk in healthy smokers and nonsmokers. [2015]
Randomized Crossover Trial Evaluating Detoxification of Tobacco Carcinogens by Broccoli Seed and Sprout Extract in Current Smokers. [2023]
Broccoli or Sulforaphane: Is It the Source or Dose That Matters? [2021]
DNA damage and repair activity after broccoli intake in young healthy smokers. [2010]
Bioavailability and inter-conversion of sulforaphane and erucin in human subjects consuming broccoli sprouts or broccoli supplement in a cross-over study design. [2022]
Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study. [2022]
Modulation of the metabolism of airborne pollutants by glucoraphanin-rich and sulforaphane-rich broccoli sprout beverages in Qidong, China. [2022]
Inhibition of urinary bladder carcinogenesis by broccoli sprouts. [2022]
Modulation of plasma antioxidant levels, glutathione S-transferase activity and DNA damage in smokers following a single portion of broccoli: a pilot study. [2014]
Broccoli (Brassica oleracea L. var. italica) Sprouts as the Potential Food Source for Bioactive Properties: A Comprehensive Study on In Vitro Disease Models. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity