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

Malignant Solid Neoplasm Clinical Trial

Official title: Phase II Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Broccoli Seed and Sprout Extract (BSSE) to Evaluate Detoxification of Carcinogens in Firefighters

Status Suspended

Clinical Trial Summary

This phase II trial tests how well broccoli seed and sprout extract (BSSE) also called Avmacol extra strength (ES) works to help break down (detoxification) some of the cancer-causing chemicals (carcinogens) that firefighters are exposed to in order to help protect cells from smoke damage. Firefighters are routinely exposed to carcinogens during the course of their daily duties particularly from smoke exposure arising from active fire rescue, structural or incidental firefighting or burning, as well as flashover training. Flashover training simulator has been specifically designed for observation and recognition of fire behavior from rollover to flashover by varying fuel loading and altering ventilation. The simulator contains the fire behavior prop with smoke coming out and air being drawn in. All fires, including those in flashover training, release toxic and carcinogenic substances. These substances, many of which are known carcinogens, increase the risk of cancer in firefighters. Several studies to date have demonstrated that firefighters are at an increased risk of developing various malignancies including melanoma, multiple myeloma, acute myeloid leukemia, prostate, kidney, brain, and respiratory tract cancers among others. Broccoli extract has the potential to effectively enhance detoxification. This study may help researchers learn how BSSE can help break down chemicals that firefighters are exposed to during flashover training to help protect their cells from smoke-damage and reduce cancer risk.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To determine whether BSSE increases the urinary excretion of mercapturic acids of the flashover training carcinogen benzene in healthy, incumbent firefighters.

SEONDARY OBJECTIVES:

I. To evaluate whether BSSE increases urinary excretion of metabolites of polycyclic aromatic hydrocarbons (PAHs).

II. To evaluate the bioavailability of BSSE measured as sulforaphane (SF) metabolites and assess its association with BSSE-induced detoxification of carcinogens.

III. To evaluate the safety and tolerability of BSSE.

EXPLORATORY OBJECTIVES:

I. To determine whether the GSTM1 and GSTT1 genotypes are important genetic modulators of BSSE-induced detoxification of carcinogens.

II. To evaluate the effects of BSSE on flashover training-induced metabolomic changes.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (BSSE-PLACEBO): Participants receive BSSE orally (PO) daily (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.

GROUP II (PLACEBO-BSSE): 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.

After completion of study treatment, patients are followed up at 1-2 weeks. ;

Related Conditions & MeSH terms

• Malignant Solid Neoplasm
• Neoplasms

• NCT number: NCT06009926
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Suspended
• Phase: Phase 2
• Start date: December 4, 2023
• Completion date: November 1, 2027