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Broccoli Extract for Cancer Risk Reduction in Firefighters

Phase 2

Recruiting

Led By Malvi Savani

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre- and post- flashover training

Awards & highlights

Study Summary

This trial tests if broccoli extract can help protect firefighters from cancer-causing chemicals in smoke, reducing their risk of cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of the broccoli extract aren't specified but may include typical reactions to supplements such as digestive discomfort. Since it's being tested for its safety and efficacy, part of the study includes monitoring for any adverse effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre- to post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre- to post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- to post-intervention 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

Secondary outcome measures

Bioavailability of BSSE

Detoxification of polyaromatic hydrocarbons (PAHs)

Incidence of adverse events

+1 more

Other outcome measures

Association of GSTM1 and GSTT1 genotypes with detoxification of benzene and/or PAHs

Changes in untargeted urinary metabolomics

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (placebo-BSSE)Experimental Treatment5 Interventions

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.

Group II: Group I (BSSE-placebo)Experimental Treatment5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo Administration

2018

Completed Phase 3

~2540

Biospecimen Collection

2004

Completed Phase 2

~1730

Broccoli Sprout/Broccoli Seed Extract Supplement

2018

Completed Early Phase 1

~50

Do I qualify?Apply below to find out

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Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,825 Total Patients Enrolled

Malvi SavaniPrincipal InvestigatorUniversity of Arizona Cancer Center - Prevention Research Clinic

Frequently Asked Questions

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

Are there any potential risks associated with the collection of biological specimens from patients?

"With no proof of efficacy, Biospecimen Collection received a score of 2 due to the availability of data that testifies towards its safety."

Answered by AI

Are there any vacancies for participants in this experiment?

"As per the data available on clinicaltrials.gov, this particular medical research is no longer open to new participants as of August 23rd, 2023 and was initially published on February 6th 2024. However, there are 2575 additional studies which are actively recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters

2023. "Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06009926.

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