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

NCT ID: NCT03429348

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-04
• Study Completion Date: 2020-02-28

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.

Conditions

Post-fire Rehabilitation of Firefighters in Sauna

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

No additional rehabilitation

No additional rehabilitation will be done

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sauna rehabilitation

An additional rehabilitation in a sauna will be done

Group Type: OTHER

Sauna Rehabilitation

Intervention Type: OTHER

Firefighters selected for sauna rehabilitation will spend time in a sauna

Interventions

Sauna Rehabilitation

Firefighters selected for sauna rehabilitation will spend time in a sauna

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jefferey L Burgess, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 17405694 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Related Links

http://www.getdetoxinated.com/docs/townsend_letter-04-2006.pdf

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

Other Identifiers

1801201082

Identifier Type: -

Identifier Source: org_study_id