Clinical trial NCT03429348: Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study
Official title: Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study, Institutional Review Board# 1801201082
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-fire Rehabilitation of Firefighters in Sauna
Keywords: Firefighter
Post-Fire Rehabilitation
Sauna
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Working with firefighters during training fire exercises, Dr. Jeff Burgess and his study team will compare a chemical commonly excreted in firefighter urine samples after firefighting to assess the value of adding sauna to rehab post-fire. Firefighter heart rate and temperature will be monitored using a core body temperature/heart rate monitor data recorder. Urine will be collected for 12 hours immediately before the scheduled training fire and for 12 hours afterwards. After the fire, the firefighter will perform the standard rehab. During this time, the University of Arizona (UA) study team will randomly select half of the firefighters to an additional sauna rehab and the other half of the firefighters to no additional rehab. Dermal (skin) wipe samples will be taken off the calf, arm, and neck before the fire, before standard rehab, and after sauna/no additional treatment. A post-fire survey will be administered.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary Excretion of Hydroxylated PAHs (PAH-OHs)
timeFrame: 12 hours for urine collection
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Jefferey L Burgess, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crinnion W. Components of practical clinical detox programs--sauna as a therapeutic tool. Altern Ther Health Med. 2007 Mar-Apr;13(2):S154-6.