Post-fire Rehabilitation of Firefighters in SaunaNCT03429348
Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study
A study testing Sauna Rehabilitation in people with Post-fire Rehabilitation of Firefighters in Sauna, run by University of Arizona at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-fire Rehabilitation of Firefighters in Sauna
- What is being tested?
- Sauna Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study, Institutional Review Board# 1801201082
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.
- Being tested
- Sauna Rehabilitation
- Keywords
- Firefighter, Post-Fire Rehabilitation, Sauna
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sauna RehabilitationOther
Firefighters selected for sauna rehabilitation will spend time in a sauna
| Study group | Role | What they receive |
|---|---|---|
| No additional rehabilitation | No intervention | No additional rehabilitation will be done |
| Sauna rehabilitation | Other | An additional rehabilitation in a sauna will be done Receives: Other: Sauna Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 hours for urine collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start4 Apr 2018
- Primary completion30 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-fire Rehabilitation of Firefighters in SaunaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jefferey L Burgess, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429348
- Sponsor's protocol ID
- 1801201082
- Status last verified
- Apr 2019
- First submitted
- 5 Feb 2018
- Last updated
- 5 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study, Institutional Review Board# 1801201082
- ClinicalTrials.gov ID
- NCT03429348
- Acronym / sponsor ID
- 1801201082
- Keywords
- Firefighter, Post-Fire Rehabilitation, Sauna
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| No additional rehabilitation | No intervention | –No additional rehabilitation will be done |
| Sauna rehabilitation | Other | Other: Sauna RehabilitationAn additional rehabilitation in a sauna will be done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sauna RehabilitationFirefighters selected for sauna rehabilitation will spend time in a sauna | Other | Sauna rehabilitation |
Primary outcome
Urinary Excretion of Hydroxylated PAHs (PAH-OHs)
Time frame: 12 hours for urine collection
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17405694Crinnion W. Components of practical clinical detox programs--sauna as a therapeutic tool. Altern Ther Health Med. 2007 Mar-Apr;13(2):S154-6.
- Use of the Hubbard Sauna Detoxification Regimen to Improve the Health Status of New York City Rescue Workers Exposed to ToxicantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jefferey L Burgess, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sauna Rehabilitation in people with Post-fire Rehabilitation of Firefighters in Sauna, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Excretion of Hydroxylated PAHs (PAH-OHs) (time frame: 12 hours for urine collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.