Broccoli Extract for Cancer Risk Reduction in Firefighters
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether a broccoli seed and sprout extract (BSSE) can aid firefighters in detoxifying harmful chemicals encountered on the job. Firefighters face an increased cancer risk due to exposure to substances like smoke and chemicals. The trial tests if daily BSSE intake can enhance the body's ability to clear these toxins. Participants will take either BSSE or a placebo for 12 weeks, with acetaminophen (Tylenol) used to measure changes in detoxification ability. Non-smoking, currently serving firefighters might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any investigational agents or certain supplements related to the study. If you are taking supplements with compounds found in cruciferous vegetables, you must stop them at least 14 days before the trial starts. Also, you need to avoid acetaminophen for 72 hours before certain evaluations.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that broccoli seed and sprout extract (BSSE) is generally safe for people. In studies, BSSE, also known as Avmacol Extra Strength, has been tested for its ability to help remove harmful substances like benzene, often found in smokers or those exposed to pollution.
Most participants in these studies did not experience serious side effects from BSSE. Some reported minor issues like stomach discomfort, but these were neither severe nor long-lasting.
Although the FDA has not yet approved BSSE, it has been tested in similar detoxification studies. The current trial is in an early stage, so researchers are still assessing its safety. However, results so far suggest that BSSE is safe for most people.
Prospective participants should consult their doctor to ensure the trial is suitable for them.12345Why do researchers think this study treatment might be promising for cancer risk reduction in firefighters?
Researchers are excited about the use of broccoli seed and sprout extract (BSSE) for reducing cancer risk in firefighters because of its unique active ingredient, sulforaphane, which is believed to help detoxify carcinogens. Unlike traditional treatments that often rely on pharmaceuticals to manage cancer risk, BSSE offers a natural, plant-based alternative. This treatment is also distinctive for its potential antioxidant properties, which may protect cells from damage caused by hazardous chemicals firefighters are exposed to during their work. Additionally, the trial incorporates acetaminophen to help assess the impact of BSSE on inflammation, providing a broader understanding of its potential benefits.
What evidence suggests that broccoli seed and sprout extract could be effective for cancer risk reduction in firefighters?
Research has shown that broccoli seed and sprout extract (BSSE) can help the body eliminate harmful substances. Studies have found that BSSE contains ingredients that activate enzymes to break down and remove toxins like benzene and polycyclic aromatic hydrocarbons (PAHs). Firefighters often encounter these toxins, which are linked to higher cancer risks. Previous research has associated BSSE with a lower risk of tobacco-related cancers, suggesting it might help reduce cancer risk. In this trial, participants in different groups will receive BSSE or a placebo, with some also receiving acetaminophen. Early findings suggest that BSSE might help the body detoxify similarly to how it processes acetaminophen, a common pain reliever. This evidence supports the idea that BSSE could effectively reduce cancer risk by enhancing detoxification processes.24678
Who Is on the Research Team?
Malvi Savani
Principal Investigator
University of Arizona Cancer Center - Prevention Research Clinic
Are You a Good Fit for This Trial?
This trial is for non-smoking firefighters aged 18 or older with normal kidney, liver, and blood cell levels. They must not have had invasive cancer in the past two years (except certain skin cancers or cervical carcinoma in situ), be on steroids, other investigational drugs, or have serious illnesses that could affect study participation. Pregnant/lactating women and those with HIV/HBV/HCV are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BSSE or placebo daily for 12 weeks, with acetaminophen challenge at baseline and end-of-intervention, and biospecimen collection throughout the study.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Broccoli Seed and Sprout Extract
Trial Overview
The trial is testing if a broccoli seed and sprout extract supplement can help firefighters detoxify harmful chemicals they're exposed to during fires. Participants will either receive this supplement or a placebo while their body's detoxification processes are monitored.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants receive BSSE PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting BSSE and once following completion of BSSE on study. Participants undergo blood and urine sample collection throughout the study.
Participants receive placebo PO QD for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive BSSE for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study. (CLOSED TO ACCRUAL 10/07/2024)
Participants receive BSSE PO QD for 7-10 days then undergo the first flashover training between day 7-10 of agent intervention. Participants then receive placebo PO QD for 7-10 days then undergo second flashover training after a washout period of 2 weeks to 3 months. Participants also undergo urine sample collection throughout the study. (CLOSED TO ACCRUAL 10/07/2024)
Participants receive placebo PO QD for 12 weeks on study. Participants also receive acetaminophen PO once prior to starting placebo and once following completion of placebo on study. Participants undergo blood and urine sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Evaluation of Broccoli Seed and Sprout Extract for ...
This phase II randomized, placebo-controlled trial evaluates whether daily supplementation with broccoli seed and sprout extract (BSSE), also known as Avmacol ...
2.
repository.arizona.edu
repository.arizona.edu/bitstream/handle/10150/667647/azu_etd_20089_sip1_m.pdf?sequence=1phase ii randomized, double-blind, placebo-controlled ...
Sprout Extract (BSSE) to Evaluate Detoxification of Carcinogens in Firefighters ... broccoli seed and sprout extract (BSSE) with results ...
3.
fredhutch.org
fredhutch.org/en/news/center-news/2021/07/cancer-prevention-broccoli-sprout-pills.htmlCancer-busting broccoli sprout pills? It's a thing.
Broccoli sprouts triggers a powerful cancer-inhibiting process. Fred Hutch researchers are exploiting it to fight disease.
Randomized Crossover Trial Evaluating Detoxification of ...
Cruciferous vegetable consumption is associated with reduced risk of tobacco-related cancers. Broccoli seed and sprout extract (BSSE) is rich in the ...
Evaluation of Broccoli Seed and Sprout Extract for ...
This phase II randomized, placebo-controlled trial evaluates whether daily supplementation with broccoli seed and sprout extract (BSSE), also known as Avmacol ...
Randomized Crossover Trial Evaluating Detoxification of ...
Cruciferous vegetable consumption is associated with reduced risk of tobacco-related cancers. Broccoli seed and sprout extract (BSSE) is ...
Broccoli Extract for Tobacco-Related Cancer Risk
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 ...
8.
aacrjournals.org
aacrjournals.org/cancerpreventionresearch/article/7/8/813/50355/Rapid-and-Sustainable-Detoxication-of-AirborneRapid and Sustainable Detoxication of Airborne Pollutants by ...
Broccoli sprouts are a convenient and rich source of the glucosinolate, glucoraphanin, which can generate the chemopreventive agent, sulforaphane, ...
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