Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05256966
Status:
SUSPENDED
Last Update Posted:
2024-06-05
First Post:
2022-01-28
Brief Title:
Firefighter Soot Sauna and Sweat Excretion Pilot Study
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Firefighter Soot Sauna and Sweat Excretion Pilot Study
Status:
SUSPENDED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interventioninteractions are temporarily paused due to a pending contract extension and are expected to resume This is not a suspension of IRB approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 carcinogens3 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 studies4-6 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 needed15 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 Objectives
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 studys 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
1 Willingness to collect urine samples before during andor after work shift
2 Willingness to refrain from eating barbecued or smoked foods during the duration of the study
3 Willingness to use a sauna after active fire suppression and to collect sweat samples at that time
Exclusion criteria
1 Declined participation in the study
2 Unwilling or do not agree to complete all data collection components of the study
3 Limited from active-duty firefighting regardless of reason
4 Medical conditions precluding the use of a sauna
5 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
1 Screening screening for eligibility and obtaining consent
2 Enrollment Collection of demographic info and instruction on sample collection
3 Data Collection Participants collect bio-samples
4 Analysis MDH analyses of lab samples statistical analysis to determine study outcomes
5 Results results provided to participants and analyzed to determine study results
6 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 005
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 characteristics 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
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 carcinogens3 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 studies4-6 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 needed15 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 Objectives
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 studys 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
1 Willingness to collect urine samples before during andor after work shift
2 Willingness to refrain from eating barbecued or smoked foods during the duration of the study
3 Willingness to use a sauna after active fire suppression and to collect sweat samples at that time
Exclusion criteria
1 Declined participation in the study
2 Unwilling or do not agree to complete all data collection components of the study
3 Limited from active-duty firefighting regardless of reason
4 Medical conditions precluding the use of a sauna
5 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
1 Screening screening for eligibility and obtaining consent
2 Enrollment Collection of demographic info and instruction on sample collection
3 Data Collection Participants collect bio-samples
4 Analysis MDH analyses of lab samples statistical analysis to determine study outcomes
5 Results results provided to participants and analyzed to determine study results
6 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 005
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 characteristics 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None