CClinicalTrials.gg
CompletedNCT03429348Updated Feb 5, 2021Results posted

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post-fire Rehabilitation of Firefighters in Sauna

Keywords

  • Firefighter
  • Post-Fire Rehabilitation
  • Sauna
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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

Interventions

  • OtherSauna Rehabilitation

    Firefighters selected for sauna rehabilitation will spend time in a sauna

05

What researchers measure

Primary outcomes

  1. 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

06

Results

Posted Feb 5, 2021
Limitations and caveats
This study involved idealized treatment conditions which included shorter intervals between exiting the fire and entry into the sauna than could likely be achieved with actual structure fires.

Participant flow

Participant flow — Overall Study
MilestoneNo Additional RehabilitationSauna Rehabilitation
Started1212
Completed1212
Not completed00

Outcome measures

PrimaryUrinary 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
Reported as:
Mean · ng/L
Urinary Excretion of Hydroxylated PAHs (PAH-OHs)
ng/LBaseline No Additional Rehabilitation Group Urine PAH-OH SumPost-fire No Additional Rehabilitation GroupBaseline Sauna Rehabilitation Group Urine PAH-OH SumPost-fire Sauna Rehabilitation Group
Urinary Excretion of Hydroxylated PAHs (PAH-OHs)10364.2 ± 2.740012.1 ± 2.66964.1 ± 1.722604.3 ± 1.6
Statistical analysis
  • Baseline Sauna Rehabilitation Group Urine PAH-OH Sum vs Post-fire Sauna Rehabilitation Group · t-test, 2 sided · p = 0.0000009 · Mean difference (final values): 1.18We are comparing the log transformed values.
  • Baseline No Additional Rehabilitation Group Urine PAH-OH Sum vs Post-fire No Additional Rehabilitation Group · t-test, 2 sided · p = 0.000018 · Mean difference (final values): 1.35We are comparing the log transformed values

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
No Additional Rehabilitation0/12 (0%)0/12 (0%)0/12 (0%)
Sauna Rehabilitation0/12 (0%)0/12 (0%)0/12 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)No Additional RehabilitationSauna RehabilitationTotal
<=18 years000
Between 18 and 65 years121224
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)No Additional RehabilitationSauna RehabilitationTotal
Female112
Male111122
Race (NIH/OMB)
Race (NIH/OMB)(Participants)No Additional RehabilitationSauna RehabilitationTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American101
White81220
More than one race101
Unknown or Not Reported101
Region of Enrollment
Region of Enrollment(participants)No Additional RehabilitationSauna RehabilitationTotal
United States121224
Urinary PAH-OHs
Urinary PAH-OHs(ng/L)No Additional RehabilitationSauna RehabilitationTotal
Mean10364.2 ± 2.76964.1 ± 1.78495.7 ± 2.2
07

Study locations

1 site
  • University of Arizona
    Tucson, Arizona 85719, United States
08

References and documents

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. PubMed 17405694 ↗

Study documents

  • Study protocol · May 14, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03429348
Lead sponsor
University of Arizona
Responsible party
Sponsor
First posted
Feb 12, 2018
Start date
Apr 4, 2018
Primary completion
Jan 30, 2020
Completion
Feb 28, 2020
Results posted
Feb 5, 2021
Last update
Feb 5, 2021

Study contacts

Jefferey L Burgess, MD
principal investigator · University of Arizona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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