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

Post-fire Rehabilitation of Firefighters in Sauna Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429348
• Other study ID #: 1801201082
• Status: Completed
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2019
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 28, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-fire Rehabilitation of Firefighters in Sauna

Intervention

Other:
• Sauna Rehabilitation
Firefighters selected for sauna rehabilitation will spend time in a sauna

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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