An interventional study of Sauna Rehabilitation in Post-fire Rehabilitation of Firefighters in Sauna, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by University of Arizona · Not applicable, Interventional, and Other
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.
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.
Cannot have any contraindications to the core temp pill, which are:
Exclusion Criteria:
No additional rehabilitation will be done
An additional rehabilitation in a sauna will be done
Other: Sauna Rehabilitation
Firefighters selected for sauna rehabilitation will spend time in a sauna
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
Time frame: 12 hours for urine collection
| Milestone | No Additional Rehabilitation | Sauna Rehabilitation |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
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
| ng/L | Baseline No Additional Rehabilitation Group Urine PAH-OH Sum | Post-fire No Additional Rehabilitation Group | Baseline Sauna Rehabilitation Group Urine PAH-OH Sum | Post-fire Sauna Rehabilitation Group |
|---|---|---|---|---|
| Urinary Excretion of Hydroxylated PAHs (PAH-OHs) | 10364.2 ± 2.7 | 40012.1 ± 2.6 | 6964.1 ± 1.7 | 22604.3 ± 1.6 |
Collected over Subjects were monitored for 12 hours following completion of their live-fire burn training exercise.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Additional Rehabilitation | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Sauna Rehabilitation | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | No Additional Rehabilitation | Sauna Rehabilitation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 12 | 24 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | No Additional Rehabilitation | Sauna Rehabilitation | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 11 | 11 | 22 |
| Race (NIH/OMB)(Participants) | No Additional Rehabilitation | Sauna Rehabilitation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 8 | 12 | 20 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | No Additional Rehabilitation | Sauna Rehabilitation | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
| Urinary PAH-OHs(ng/L) | No Additional Rehabilitation | Sauna Rehabilitation | Total |
|---|---|---|---|
| Mean | 10364.2 ± 2.7 | 6964.1 ± 1.7 | 8495.7 ± 2.2 |
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University of Arizona