HyperthermiaPhase 1NCT01905098
Complementary and Alternative Medicine Sauna Detoxification Study: Phase I
A Phase 1 study testing Sauna Detoxification Protocol and Observation Sessions in people with Hyperthermia, run by Bastyr University at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of sauna use on polychlorinated biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety, feasibility, and tolerability, and effects on quality of life and wellness. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia
- What is being tested?
- Sauna Detoxification Protocol and Observation Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Apr 2014
- Phase
- Phase 1
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-35 years.
- Body mass index (BMI) 19 to 29.9 kg/m2 at the screening evaluation.
- Ability to schedule and attend daily visits for the duration of the study.
- If female, willingness to use barrier contraception (e.g., cervical cap, diaphragm, condom, metal (non- hormone) Intrauterine Device (IUD) throughout the study and take a pregnancy test at screening and weekly during the study.
Who cannot join
- Pregnant, or trying to become pregnant in the three months following screening.
- Current use of any prescribed pharmaceutical medications (including oral contraceptive pills (OCPs) and dietary supplements).
- Refusal to stop taking self-prescribed dietary supplements and OCPs for the duration of the study.
- BMI greater than 29.9 kg/m2 or less than 19 kg/m2.
- Elevated fasting blood sugar (above 125 mg/dL).
- Abnormal ECG findings of: bradycardia (heart rate below 60) not due to athletic bradycardia, ventricular arrhythmias, axis deviation, coronary circulation problems (ischemia/infarct/injury), or any activation sequence disorders (e.g. Right/Left Bundle Branch Block (RBBB/LBBB) and Wolff-Parkinson-White Syndrome (WPW).)
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- Hyper or hypotension (BP above 180/100 or below 80/50 respectively).
- A reported diagnosis of any chronic medical condition (e.g., multiple sclerosis, diabetes, or endocrine disorders, liver disease, kidney disease, HIV/AIDS, or cancer), or with a reported history of substance abuse or mental illness within the past 5 years, or a mental health disorder in the past 6 months.
- CBC/D, ALT-Liver Protein, AST-Liver Protein, Blood Urea Nitrogen (BUN), or Creatinine outside of 15% of the Lower/Upper Limit of Normal (LLN/ULN) values.
- Recent infection (<14 days), open sores, or communicable skin conditions.
- Current reported use of any tobacco products or illicit drugs.
- Any condition that, in the opinion of the investigators or Institutional Review Board (IRB), would preclude the safe completion of the study (e.g., clinical or mental health concerns that arise from the overall screening or medical history assessment).
- Previous participation in the pilot sauna detoxification study, and/or participation in a detoxification program within the last 6 months of the Phone Screen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bastyr University Research Institute, Clinical Research Center
Kenmore, Washington, 98028
About this study
Official title: Complementary and Alternative Medicine Sauna Detoxification Study: A Phase I Randomized 2-Arm Study to Determine the Impact of Hyperthermia Intervention Protocol on Serum Polychlorinated Biphenyls (PCBs) in Healthy Human Adults.
The purpose of this study is to determine the impact of sauna use on polychlorinated biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety, feasibility, and tolerability, and effects on quality of life and wellness. We hope to determine if there is a link between lower PCB levels in blood and sauna use.
Read the detailed description
This is a Phase I, 2-Arm randomized trial.
All study participants will actively undergo sauna intervention sessions and observation sessions.
The time between Phone Screen and the End of Study Visit will vary by individual schedule. For the purposes of this study, a participant will be considered 'actively enrolled' when s/he has signed the Full Study Consent Form on the first sauna or observation visit (SV1 or OV1). Each participant will be actively enrolled for at least 7 weeks, but no more than 22 weeks.
All participants will undergo Phone Screen for eligibility prior to participating in any study-related visits. Candidates will first be asked for their oral consent to be screened, and if granted, questioning will continue. If the participant meets pre-screening criteria assessed on the phone, they will be asked to schedule an In-Person Screening Visit.
Prior to randomization, all participants will participate in an In-Person Screening Visit at the Bastyr University (BU) Clinical Research Center (CRC) for: informed consent, to have a blood draw for screening lab analysis, anthropomorphic measurements, a 12-lead ECG assessment, provide demographic data, and medical history assessment.
If participants remain interested and eligible, they will be randomized into either Sauna-First Arm or Observation-First Arm within 2 weeks of eligibility ascertainment using block randomization scheme.
Participants will know that they are in an intervention, but will not know their PCB levels, or the results of questionnaire assessments until approximately three months after the end of the study. The PI will review monitoring and AE data, but will be blinded to PCB data during analysis.
After screening, randomization, and informed consent, study participants in either Arm will either complete a 3-week observation period followed by a 3-week medically monitored sauna-based detoxification intervention; or will first complete a 3-week medically monitored sauna-based detoxification intervention, followed by a 3-week observation period. Each participant will also have an End of Study Visit at least 7 days after the last study visit (Sauna or Observation Visit -depending on the Arm).
The sauna will be pre-warmed to 160 degrees Fahrenheit and humidity set to 25% +/- 5%. Participants will have a scheduled 10-min break every 30 minutes of sauna, during which time vital signs, symptoms, and fluid intake will be assessed and recorded.
During Sauna Visits weekly lab assessments will be performed to compare participants' baseline lab values with those during the sauna intervention, and to monitor for safety. In addition, weekly serum samples will be taken for PCB assessment.
During each Observation Visit a blood draw for Complete Blood Count with Differential (CBC/D), Comprehensive Metabolic Panel (CMP), and PCBs analysis will be performed, as well as query for symptoms and MOSES questionnaire will be assessed.
- Conditions
- Hyperthermia
- Being tested
- Sauna Detoxification Protocol, Observation Sessions
- Keywords
- Detoxification, Sauna, Hyperthermia
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sauna Detoxification ProtocolOther
Also called Sauna-based detoxification
All study participants will actively undergo sauna intervention sessions.
The sauna will be pre-warmed to 160 degrees Fahrenheit and humidity set to 25% +/- 5%. Participants will have a scheduled 10-min break every 30 minutes of sauna, during which time vital signs, symptoms, and fluid intake will be assessed and recorded.
On a weekly basis, lab assessments will be performed to compare participants' baseline lab values with those during the sauna intervention, and to monitor for safety. In addition, weekly serum samples will be taken for PCB assessment.
Observation SessionsOther
All enrolled participants will undergo observation protocol consisting of one (1) hour visit weekly consistent with Sauna Visits lab assessment time points, to be completed in 3 weeks (4 total sessions within 21 days). At each Observation Visit a blood draw for CBC/D, CMP, and PCBs analysis will be performed, as well as query for symptoms and MOSES questionnaire will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Observation-First Arm | Experimental | A group that first attends 4 observation visits without sauna, and then attends sauna sessions 5 times a week for 3.5 hours per visit for 3 weeks.
Participants in this Arm will undergo both listed interventions: Observation and Sauna Protocols. Receives: Other: Sauna Detoxification Protocol; Other: Observation Sessions |
| Sauna-First Arm | Active comparator | A group that first attends sauna sessions 5 times a week for 3.5 hours per visit for 3 weeks and then attends 4 observation visits without sauna.
Participants in this Arm will undergo both listed interventions: Observation and Sauna Protocols. Receives: Other: Sauna Detoxification Protocol; Other: Observation Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of sauna protocol on PCB levels
The primary comparison measure will be PCB levels at Sauna Visit 15 in the sauna-first Arm and Observation Visit 4 in the Observation-First Arm.
Measured: 6 weeks
Safety
To evaluate the safety of sauna detoxification by recording and describing all adverse events (AE's) throughout the study.
Measured: 6 weeks
Secondary outcomes (1)
Participant-Reported Symptoms
To describe changes in quality of life and participant-reported symptoms associated with participation in the study.
Query for symptoms will be recorded daily during all sauna visits (SV1-15), at each observation visit (OV1-4), and at the End of Study Visit.
The RAND Short Form 36 Questionnaire, and NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaires: Global Wellness, Fatigue, Physical Function will be assessed at SV1, OV1, and End of Study Visit.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies 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 1
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Jason Allen, ND, MPH, Principal investigator, Bastyr University Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905098
- Sponsor's protocol ID
- H35B11-Phase1
- Other IDs
- 5R00AT004711-04
- Status last verified
- Apr 2015
- First submitted
- 16 Jul 2013
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary and Alternative Medicine Sauna Detoxification Study: A Phase I Randomized 2-Arm Study to Determine the Impact of Hyperthermia Intervention Protocol on Serum Polychlorinated Biphenyls (PCBs) in Healthy Human Adults.
- ClinicalTrials.gov ID
- NCT01905098
- Acronym / sponsor ID
- H35B11-Phase1
- Conditions
- Hyperthermia
- Keywords
- Detoxification, Sauna, Hyperthermia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Jul 2013 (estimated)
- 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 this study is to determine the impact of sauna use on polychlorinated biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety, feasibility, and tolerability, and effects on quality of life and wellness. We hope to determine if there is a link between lower PCB levels in blood and sauna use.
Detailed description
This is a Phase I, 2-Arm randomized trial.
All study participants will actively undergo sauna intervention sessions and observation sessions.
The time between Phone Screen and the End of Study Visit will vary by individual schedule. For the purposes of this study, a participant will be considered 'actively enrolled' when s/he has signed the Full Study Consent Form on the first sauna or observation visit (SV1 or OV1). Each participant will be actively enrolled for at least 7 weeks, but no more than 22 weeks.
All participants will undergo Phone Screen for eligibility prior to participating in any study-related visits. Candidates will first be asked for their oral consent to be screened, and if granted, questioning will continue. If the participant meets pre-screening criteria assessed on the phone, they will be asked to schedule an In-Person Screening Visit.
Prior to randomization, all participants will participate in an In-Person Screening Visit at the Bastyr University (BU) Clinical Research Center (CRC) for: informed consent, to have a blood draw for screening lab analysis, anthropomorphic measurements, a 12-lead ECG assessment, provide demographic data, and medical history assessment.
If participants remain interested and eligible, they will be randomized into either Sauna-First Arm or Observation-First Arm within 2 weeks of eligibility ascertainment using block randomization scheme.
Participants will know that they are in an intervention, but will not know their PCB levels, or the results of questionnaire assessments until approximately three months after the end of the study. The PI will review monitoring and AE data, but will be blinded to PCB data during analysis.
After screening, randomization, and informed consent, study participants in either Arm will either complete a 3-week observation period followed by a 3-week medically monitored sauna-based detoxification intervention; or will first complete a 3-week medically monitored sauna-based detoxification intervention, followed by a 3-week observation period. Each participant will also have an End of Study Visit at least 7 days after the last study visit (Sauna or Observation Visit -depending on the Arm).
The sauna will be pre-warmed to 160 degrees Fahrenheit and humidity set to 25% +/- 5%. Participants will have a scheduled 10-min break every 30 minutes of sauna, during which time vital signs, symptoms, and fluid intake will be assessed and recorded.
During Sauna Visits weekly lab assessments will be performed to compare participants' baseline lab values with those during the sauna intervention, and to monitor for safety. In addition, weekly serum samples will be taken for PCB assessment.
During each Observation Visit a blood draw for Complete Blood Count with Differential (CBC/D), Comprehensive Metabolic Panel (CMP), and PCBs analysis will be performed, as well as query for symptoms and MOSES questionnaire will be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation-First Arm | Experimental | Other: Sauna Detoxification Protocol, Other: Observation SessionsA group that first attends 4 observation visits without sauna, and then attends sauna sessions 5 times a week for 3.5 hours per visit for 3 weeks. Participants in this Arm will undergo both listed interventions: Observation and Sauna Protocols. |
| Sauna-First Arm | Active comparator | Other: Sauna Detoxification Protocol, Other: Observation SessionsA group that first attends sauna sessions 5 times a week for 3.5 hours per visit for 3 weeks and then attends 4 observation visits without sauna. Participants in this Arm will undergo both listed interventions: Observation and Sauna Protocols. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 21-35 years.
- Body mass index (BMI) 19 to 29.9 kg/m2 at the screening evaluation.
- Ability to schedule and attend daily visits for the duration of the study.
- If female, willingness to use barrier contraception (e.g., cervical cap, diaphragm, condom, metal (non- hormone) Intrauterine Device (IUD) throughout the study and take a pregnancy test at screening and weekly during the study.
Key exclusion criteria (13 listed)
- Pregnant, or trying to become pregnant in the three months following screening.
- Current use of any prescribed pharmaceutical medications (including oral contraceptive pills (OCPs) and dietary supplements).
- Refusal to stop taking self-prescribed dietary supplements and OCPs for the duration of the study.
- BMI greater than 29.9 kg/m2 or less than 19 kg/m2.
- Elevated fasting blood sugar (above 125 mg/dL).
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 Detoxification ProtocolAlso: Sauna-based detoxificationAll study participants will actively undergo sauna intervention sessions. The sauna will be pre-warmed to 160 degrees Fahrenheit and humidity set to 25% +/- 5%. Participants will have a scheduled 10-min break every 30 minutes of sauna, during which time vital signs, symptoms, and fluid intake will be assessed and recorded. On a weekly basis, lab assessments will be performed to compare participants' baseline lab values with those during the sauna intervention, and to monitor for safety. In addition, weekly serum samples will be taken for PCB assessment. | Other | Observation-First Arm, Sauna-First Arm |
| Observation SessionsAll enrolled participants will undergo observation protocol consisting of one (1) hour visit weekly consistent with Sauna Visits lab assessment time points, to be completed in 3 weeks (4 total sessions within 21 days). At each Observation Visit a blood draw for CBC/D, CMP, and PCBs analysis will be performed, as well as query for symptoms and MOSES questionnaire will be assessed. | Other | Observation-First Arm, Sauna-First Arm |
Primary outcome
Impact of sauna protocol on PCB levels
Time frame: 6 weeks
The primary comparison measure will be PCB levels at Sauna Visit 15 in the sauna-first Arm and Observation Visit 4 in the Observation-First Arm.
Safety
Time frame: 6 weeks
To evaluate the safety of sauna detoxification by recording and describing all adverse events (AE's) throughout the study.
1 secondary outcome
Participant-Reported Symptoms
Time frame: 6 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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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.
Jason Allen, ND, MPH principal investigator
Bastyr University Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sauna Detoxification Protocol and Observation Sessions in people with Hyperthermia, run by Bastyr University 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 4 inclusion and 13 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: stopped early, as of the sponsor's last update on 17 Apr 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Impact of sauna protocol on PCB levels (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 17 Apr 2015.