Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study

Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study, Institutional Review Board# 1801201082

Firefighters are at increased risk of cancer, and both inhalation and dermal routes contribute to overall exposure to carcinogens, including polycyclic aromatic hydrocarbons (PAHs). The purpose of the current study is to determine if post-fire firefighter rehabilitation in an infrared sauna: a) affects absorption of PAHs as measured by urinary metabolites; and b) changes core body temperature and heart rate.

Study Overview

• Status: Completed
• Conditions: Post-fire Rehabilitation of Firefighters in Sauna
• Intervention / Treatment: Other: Sauna Rehabilitation

Detailed Description

An initial four firefighters will be evaluated for change in PAHs associated with standard fire department flashover training to determine if urinary PAH metabolites increase following exposure, comparing baseline urine samples (collected for up to 12 hours before the training fire) to a repeat urine sample (collected up to 12 hours after cessation of the training fire.) If a significant increase is not seen, then repeat testing with four firefighters will be completed using burn room training scenarios. Air monitoring during the training periods may be carried out with standard industrial hygiene instruments.

Stage 2: Once a significant increase in PAHs has been documented, the associated training scenario (flashover training or alternate live fire training), testing will be carried out in 20 subjects. Prior to starting the training scenario, the firefighters will provide a urine sample (collected over a time period of 12 hours prior to the training fire), swallow a core temperature probe and wear a monitor for recording both their core temperature and heart rate. In addition, dermal wipes will be collected prior to the training fire. Air monitoring during the training periods will be carried out with standard industrial hygiene instruments. Following cessation of the training scenario, the subjects will follow their standard fire department procedures, which may involve using skin wipes and showering. The subjects will then be randomized to either an infrared sauna treatment, with or without exercising as determined by the fire department protocol, or no additional treatment, following their fire department protocols. Repeat dermal wipes will be collected in all subjects. Core temperature and heart rate will be monitored for up to 8 hours after training scenario. The subjects will collect all their urine after the fire training for a period of 12 hours. The urine will be analyzed for urinary PAH metabolites and potentially other toxicants from the fire, and, dependent on the available budget, similar evaluations may be carried out on the skin wipes.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are employed as an active fire responder by the Fire Department
• Are scheduled for a training fire exercise by the Fire Department in the next year
• Are currently a non-smoker (including cigarettes, cigars and e-cigarettes)

• Cannot have any contraindications to the core temp pill, which are:

  • weight less than 80 pounds
  • known or suspected obstructive disease of GI tract, including but not limited to diverticulitis and inflammatory bowel disease
  • exhibit or have a history of disorders or impairment of the gag reflex
  • have had a previous gastrointestinal surgery
  • have any diseases or disorders of the esophagus
  • will be undergoing Nuclear Magnetic Resonance (NMR) or MRI scanning less than 3 days after swallowing the sensor
  • have a low motility disorder of the gastrointestinal tract including but not limited to ileus
  • have a cardiac pacemaker or other implanted electromedical device
  • have a swallowing disorder

Exclusion Criteria:

• Are NOT employed as an active fire responder by the Fire Department
• Are NOT scheduled for a training fire exercise by the Fire Department in the next year
• Are currently a smoker (including cigarettes, cigars and e-cigarettes)
• Has one of the contraindications to the core temp pill

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No additional rehabilitation; No additional rehabilitation will be done
Other: Sauna rehabilitation; An additional rehabilitation in a sauna will be done	Other: Sauna Rehabilitation; Firefighters selected for sauna rehabilitation will spend time in a sauna

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Excretion of Hydroxylated PAHs (PAH-OHs)	Urine samples from firefighters post-fire will be measured for hydroxylated PAHs (PAH-OHs) and the concentration compared to pre-fire urine concentrations of PAH-OHs	12 hours for urine collection

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Jefferey L Burgess, MD, University of Arizona

Publications and helpful links

General Publications

• Crinnion W. Components of practical clinical detox programs--sauna as a therapeutic tool. Altern Ther Health Med. 2007 Mar-Apr;13(2):S154-6.

Helpful Links

• Use of the Hubbard Sauna Detoxification Regimen to Improve the Health Status of New York City Rescue Workers Exposed to Toxicants

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Sauna; Firefighter; Post-Fire Rehabilitation
• Other Study ID Numbers: 1801201082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No