CancerNCT05256966
Firefighter Soot, Sauna, and Sweat Excretion Pilot Study
A study testing Sauna (steam) in people with Cancer, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of the study is to evaluate whether sauna use after active-duty firefighting is effective in reducing exposure to certain harmful chemicals called polycyclic aromatic hydrocarbons (PAHs). PAHs are found in soot and several types are known to be carcinogens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Sauna (steam)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Willingness to collect urine samples before, during, and/or after work shift
- Willingness to refrain from eating barbecued or smoked foods during the duration of the study
- Willingness to use a sauna after active fire suppression and to collect sweat samples at that time
Who cannot join
- Declined participation in the study
- Unwilling or do not agree to complete all data collection components of the study
- Limited from active-duty firefighting (regardless of reason)
- Medical conditions precluding the use of a sauna
- Pregnancy (as sauna use is contraindicated in pregnancy)
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Institute
Minneapolis, Minnesota, 55403
About this study
The purpose of the study is to evaluate whether sauna use after active-duty firefighting is effective in reducing exposure to certain harmful chemicals called polycyclic aromatic hydrocarbons (PAHs). PAHs are found in soot and several types are known to be carcinogens.
This study is a cross-sectional pilot study that will be performed in active-duty firefighters. The firefighters will be subdivided into those who will use a sauna immediately after fighting a fire versus those who will not, the latter of which will serve as a metabolism control group. There will thus be two comparison groups within the study: 1) active-duty firefighters using a sauna after fire suppression (sauna group); 2) active-duty firefighters not using a sauna after fire suppression (metabolism control).
Read the detailed description
Study Rationale
Firefighters are exposed to toxic materials during fire suppression activities and have a higher rate of cancer than the general population, despite a high level of physical fitness. Some studies suggest the use of sauna (infrared or traditional) may increase excretion of harmful and toxic chemicals. Biomonitoring is the measure of chemicals or metabolites present in the human body and is used to evaluate exposure. This proposed study is a biomonitoring pilot study to evaluate the effectiveness of use of a sauna at modulating excretion of select classes of chemicals from firefighters.
One of the most well-established occupational hazards to firefighters is soot, the black particulate matter generated during combustion of organic materials. The chemical composition of soot varies based on the original material undergoing combustion, but the primary organic components of soot comprises a class of compounds known as polycyclic aromatic hydrocarbons (PAHs), which includes many carcinogens.3 PAH exposure can be measured through the analysis of hydroxy metabolites (OH-PAHs) in urine, the methods of which are well-established and have been conducted in the general population and in firefighters in several studies.4-6 The existing literature evaluating excretion of compounds via sweat is suggestive that some compounds may be more quickly eliminated by inducing sweating, such as via use of the sauna. There is a lack of standardization in sweat biomonitoring and further development of these methods is still needed.15 This proposed pilot study will contribute to the biomonitoring literature particularly in the firefighting population by addressing the gaps in knowledge of whether PAHs are excreted in sweat, and whether use of a sauna can affect rates of PAH excretion in firefighters.
Study Objective(s)
Aim 1. This study aims to demonstrate that sauna use immediately after active-duty firefighting will result in measurable (above the level of detection) PAH biomarkers in sweat.
Aim 2. This study secondarily aims to demonstrate that sauna use immediately after active-duty firefighting will result in significantly different mean levels of PAH biomarkers in urine as compared to no use of a sauna.
Study Design
This study is a cross-sectional pilot study that will be performed in active-duty firefighters. The firefighters will be subdivided into those who will use a sauna immediately after fighting a fire versus those who will not, the latter of which will serve as a metabolism control group. There will thus be two comparison groups within the study: 1) active-duty firefighters using a sauna after fire suppression (sauna group); 2) active-duty firefighters not using a sauna after fire suppression (metabolism control).
Subject Population
This study's population is established based on convenience, as the St. Paul Fire Department already has a single station where a sauna has been installed for several decades. The study intervention population will include St. Paul Firefighters working within Station 4, the only station at present where a sauna is installed. The metabolism control group will include St. Paul Firefighters working in stations 7 and 17, who may be called to actively perform at the same fires as the firefighters at Station 4.
St. Paul Firefighters work full-time, on 24-hour shifts, with three different shifts delineated. Station 4 comprises 9 firefighters across 3 shifts, totaling 27 firefighters. The study will be opened to all firefighters in the St. Paul Fire Department, and the Department Chief and department staff will work to schedule individuals enrolled into the study to work at Station 4, 7, or 17.
Inclusion criteria:
- Willingness to collect urine samples before, during, and/or after work shift
- Willingness to refrain from eating barbecued or smoked foods during the duration of the study
- Willingness to use a sauna after active fire suppression and to collect sweat samples at that time
Exclusion criteria:
- Declined participation in the study
- Unwilling or do not agree to complete all data collection components of the study
- Limited from active-duty firefighting (regardless of reason)
- Medical conditions precluding the use of a sauna
- Pregnancy (as sauna use is contraindicated in pregnancy)
Number Of Subjects
A minimum of 20 people (10 per group) and a maximum of 60 people (30 per group) will be recruited. As this is a convenience sample, and as not all possible individuals within each sample subpopulation may opt to participate in this study, these samples may be drawn from the same individuals after different active fire runs. Each participant may be asked to provide biosamples up to four times.
The sauna group will comprise 30 urine and 30 sweat samples, whereas the metabolism control group will comprise 30 urine samples, totaling 90 study samples for analysis. The study sample size is limited on resources available for conducting this study and processing samples, and is not intended to meet statistical significance as much as demonstrate differential exposures to PAHs and metabolism of PAHs in the context of this pilot study.
Study Duration
Each subject will be asked to contribute biosamples up to four times. The biosample collection phase is expected to last approximately three months.
The entire study is expected to last 12 months. Study Phases
- Screening: screening for eligibility and obtaining consent
- Enrollment: Collection of demographic info and instruction on sample collection
- Data Collection: Participants collect bio-samples
- Analysis: MDH analyses of lab samples; statistical analysis to determine study outcomes
- Results: results provided to participants and analyzed to determine study results
- Publication: writing and publication of manuscript Statistical And Analytic Plan Statistical testing will comprise a two-tailed t-test (or non-parametric equivalent test if conditions of normality are not met), where statistical significance will be considered at a p-value of <= 0.05.
Aim 1. Detection of PAH parent compounds and metabolites in sweat. Number of detections will be descriptively reported in addition to means and standard deviations of those samples above the report levels.
Aim 2. Comparison of urine PAH biomarkers in sauna group versus metabolism control group. A statistical test of means will be performed on the mean levels of urine PAH biomarkers in the sauna group and the metabolism control group.
The Investigators will use a chi-square test to compare the baseline characteristics of the two groups. If the investigators find a significant difference, the investigators will plan on adjusting for the role of the participant in analysis. Similarly, if the investigators find other baseline characteristic(s) to significantly differ between groups, the investigators will adjust for those variables using multivariate regression that includes treatment group as a variable (Sauna, Metabolism) along with the variables that are unbalanced between the groups.
Statistical analysis will be conducted by the principal investigator (Dr. Zeke McKinney) with the assistance of the Research Methodology Group at the HealthPartners Institute.
- Conditions
- Cancer
- Being tested
- Sauna (steam)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sauna (steam)Other
Steam Sauna
| Study group | Role | What they receive |
|---|---|---|
| Sauna | Active comparator | Firefighters/participants based at the station with an existing sauna will be allocated to the intervention arm/sauna group. They will include a sauna session, as per study protocol, which is the intervention. Receives: Other: Sauna (steam) |
| Non Sauna | No intervention | Firefighters/participants based at the stations without a sauna will be allocated to the control arm/Non sauna group. They will not sauna, as per study protocol, as to not receive the study intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of PAHs present in sweat
This study aims to demonstrate that sauna use immediately after active-duty firefighting will result in a change of PAH biomarkers measurable in sweat.
Measured: Through study completion, when 90 matched samples have been collected
Secondary outcomes (1)
Change in PAHs present in urine
This study secondarily aims to demonstrate that sauna use immediately after active-duty firefighting will result in significantly changed mean levels of PAH biomarkers in urine as compared to no use of a sauna.
Measured: Through study completion, when 90 matched samples have been collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Nov 2021
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Department of Health
- Responsible party
- Sponsor
- Investigators
- Zeke McKinney, MD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256966
- Sponsor's protocol ID
- A19-131
- Status last verified
- Jul 2025
- First submitted
- 28 Jan 2022
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Firefighter Soot, Sauna, and Sweat Excretion Pilot Study
- ClinicalTrials.gov ID
- NCT05256966
- Acronym / sponsor ID
- A19-131
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Minnesota Department of Health
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate whether sauna use after active-duty firefighting is effective in reducing exposure to certain harmful chemicals called polycyclic aromatic hydrocarbons (PAHs). PAHs are found in soot and several types are known to be carcinogens.
This study is a cross-sectional pilot study that will be performed in active-duty firefighters. The firefighters will be subdivided into those who will use a sauna immediately after fighting a fire versus those who will not, the latter of which will serve as a metabolism control group. There will thus be two comparison groups within the study: 1) active-duty firefighters using a sauna after fire suppression (sauna group); 2) active-duty firefighters not using a sauna after fire suppression (metabolism control).
Detailed description
Study Rationale
Firefighters are exposed to toxic materials during fire suppression activities and have a higher rate of cancer than the general population, despite a high level of physical fitness. Some studies suggest the use of sauna (infrared or traditional) may increase excretion of harmful and toxic chemicals. Biomonitoring is the measure of chemicals or metabolites present in the human body and is used to evaluate exposure. This proposed study is a biomonitoring pilot study to evaluate the effectiveness of use of a sauna at modulating excretion of select classes of chemicals from firefighters.
One of the most well-established occupational hazards to firefighters is soot, the black particulate matter generated during combustion of organic materials. The chemical composition of soot varies based on the original material undergoing combustion, but the primary organic components of soot comprises a class of compounds known as polycyclic aromatic hydrocarbons (PAHs), which includes many carcinogens.3 PAH exposure can be measured through the analysis of hydroxy metabolites (OH-PAHs) in urine, the methods of which are well-established and have been conducted in the general population and in firefighters in several studies.4-6 The existing literature evaluating excretion of compounds via sweat is suggestive that some compounds may be more quickly eliminated by inducing sweating, such as via use of the sauna. There is a lack of standardization in sweat biomonitoring and further development of these methods is still needed.15 This proposed pilot study will contribute to the biomonitoring literature particularly in the firefighting population by addressing the gaps in knowledge of whether PAHs are excreted in sweat, and whether use of a sauna can affect rates of PAH excretion in firefighters.
Study Objective(s)
Aim 1. This study aims to demonstrate that sauna use immediately after active-duty firefighting will result in measurable (above the level of detection) PAH biomarkers in sweat.
Aim 2. This study secondarily aims to demonstrate that sauna use immediately after active-duty firefighting will result in significantly different mean levels of PAH biomarkers in urine as compared to no use of a sauna.
Study Design
This study is a cross-sectional pilot study that will be performed in active-duty firefighters. The firefighters will be subdivided into those who will use a sauna immediately after fighting a fire versus those who will not, the latter of which will serve as a metabolism control group. There will thus be two comparison groups within the study: 1) active-duty firefighters using a sauna after fire suppression (sauna group); 2) active-duty firefighters not using a sauna after fire suppression (metabolism control).
Subject Population
This study's population is established based on convenience, as the St. Paul Fire Department already has a single station where a sauna has been installed for several decades. The study intervention population will include St. Paul Firefighters working within Station 4, the only station at present where a sauna is installed. The metabolism control group will include St. Paul Firefighters working in stations 7 and 17, who may be called to actively perform at the same fires as the firefighters at Station 4.
St. Paul Firefighters work full-time, on 24-hour shifts, with three different shifts delineated. Station 4 comprises 9 firefighters across 3 shifts, totaling 27 firefighters. The study will be opened to all firefighters in the St. Paul Fire Department, and the Department Chief and department staff will work to schedule individuals enrolled into the study to work at Station 4, 7, or 17.
Inclusion criteria:
- Willingness to collect urine samples before, during, and/or after work shift
- Willingness to refrain from eating barbecued or smoked foods during the duration of the study
- Willingness to use a sauna after active fire suppression and to collect sweat samples at that time
Exclusion criteria:
- Declined participation in the study
- Unwilling or do not agree to complete all data collection components of the study
- Limited from active-duty firefighting (regardless of reason)
- Medical conditions precluding the use of a sauna
- Pregnancy (as sauna use is contraindicated in pregnancy)
Number Of Subjects
A minimum of 20 people (10 per group) and a maximum of 60 people (30 per group) will be recruited. As this is a convenience sample, and as not all possible individuals within each sample subpopulation may opt to participate in this study, these samples may be drawn from the same individuals after different active fire runs. Each participant may be asked to provide biosamples up to four times.
The sauna group will comprise 30 urine and 30 sweat samples, whereas the metabolism control group will comprise 30 urine samples, totaling 90 study samples for analysis. The study sample size is limited on resources available for conducting this study and processing samples, and is not intended to meet statistical significance as much as demonstrate differential exposures to PAHs and metabolism of PAHs in the context of this pilot study.
Study Duration
Each subject will be asked to contribute biosamples up to four times. The biosample collection phase is expected to last approximately three months.
The entire study is expected to last 12 months. Study Phases
- Screening: screening for eligibility and obtaining consent
- Enrollment: Collection of demographic info and instruction on sample collection
- Data Collection: Participants collect bio-samples
- Analysis: MDH analyses of lab samples; statistical analysis to determine study outcomes
- Results: results provided to participants and analyzed to determine study results
- Publication: writing and publication of manuscript Statistical And Analytic Plan Statistical testing will comprise a two-tailed t-test (or non-parametric equivalent test if conditions of normality are not met), where statistical significance will be considered at a p-value of <= 0.05.
Aim 1. Detection of PAH parent compounds and metabolites in sweat. Number of detections will be descriptively reported in addition to means and standard deviations of those samples above the report levels.
Aim 2. Comparison of urine PAH biomarkers in sauna group versus metabolism control group. A statistical test of means will be performed on the mean levels of urine PAH biomarkers in the sauna group and the metabolism control group.
The Investigators will use a chi-square test to compare the baseline characteristics of the two groups. If the investigators find a significant difference, the investigators will plan on adjusting for the role of the participant in analysis. Similarly, if the investigators find other baseline characteristic(s) to significantly differ between groups, the investigators will adjust for those variables using multivariate regression that includes treatment group as a variable (Sauna, Metabolism) along with the variables that are unbalanced between the groups.
Statistical analysis will be conducted by the principal investigator (Dr. Zeke McKinney) with the assistance of the Research Methodology Group at the HealthPartners Institute.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sauna | Active comparator | Other: Sauna (steam)Firefighters/participants based at the station with an existing sauna will be allocated to the intervention arm/sauna group. They will include a sauna session, as per study protocol, which is the intervention. |
| Non Sauna | No intervention | –Firefighters/participants based at the stations without a sauna will be allocated to the control arm/Non sauna group. They will not sauna, as per study protocol, as to not receive the study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness to collect urine samples before, during, and/or after work shift
- Willingness to refrain from eating barbecued or smoked foods during the duration of the study
- Willingness to use a sauna after active fire suppression and to collect sweat samples at that time
Key exclusion criteria (5 listed)
- Declined participation in the study
- Unwilling or do not agree to complete all data collection components of the study
- Limited from active-duty firefighting (regardless of reason)
- Medical conditions precluding the use of a sauna
- Pregnancy (as sauna use is contraindicated in pregnancy)
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 (steam)Steam Sauna | Other | Sauna |
Primary outcome
Change of PAHs present in sweat
Time frame: Through study completion, when 90 matched samples have been collected
This study aims to demonstrate that sauna use immediately after active-duty firefighting will result in a change of PAH biomarkers measurable in sweat.
1 secondary outcome
Change in PAHs present in urine
Time frame: Through study completion, when 90 matched samples have been collected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Zeke McKinney, MD principal investigator
HealthPartners Institute
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 (steam) in people with Cancer, run by HealthPartners Institute 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 3 inclusion and 5 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 15 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of PAHs present in sweat (time frame: Through study completion, when 90 matched samples have been collected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.