HyperthermiaPhase 1NCT01576822
Sauna Detoxification Study: Pilot Feasibility
A Phase 1 study testing This protocol will utilize a sauna as the primary method of detoxification. in people with Hyperthermia, run by Bastyr University at 1 site in United States.
Trial summary
The goal of this study is to assess the feasibility of the approach, conduct a dose-finding investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials in the assessment of human chemical body burden reduction, for general wellness, detoxification, and pain reduction. 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?
- This protocol will utilize a sauna as the primary method of detoxification.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 2012
- 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 30 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 IUD (non- hormone)) 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, without additional barrier contraception).
- Participants who have a BMI greater than 30 kg/m2, elevated fasting blood sugar, bradycardia, hyper or hypotension or evidence of a medical condition.
- A 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.
- Clinical chemistry lab values outside of reference lab normal ranges (except in cases of ranges within 10% ULN and isolated measurements in the absence of chronic disease).
- Recent infection (<14 days), open sores, or communicable skin conditions.
- Current use of any tobacco products or illicit drugs.
- Any condition that in the opinion of the investigators or IRB would preclude the safe completion of the study (e.g., clinical or mental health concerns that arise from the screening questionnaire or physical exam).
Trial locations and contacts
1 site in 1 country.
United States1 site
Bastyr University Clinical Research Center
Kenmore, Washington, 98028
About this study
Official title: Complementary and Alternative Medicine Detoxification: Safety and Efficacy
The goal of this study is to assess the feasibility of the approach, conduct a dose-finding investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials in the assessment of human chemical body burden reduction, for general wellness, detoxification, and pain reduction.
The investigators wish to determine if a hyperthermia-based detoxification protocol is feasible to conduct: including assessment of recruitment, enrollment, retention, protocol adherence, adverse events, and changes in serum polychlorinated biphenyls (PCBs).
Read the detailed description
According to our nationwide survey of Naturopathic Physicians regarding use of detoxification, approximately 80 percent of NDs (Naturopathic Doctors) use some type of detoxification interventions in clinical practice on a regular basis. Of the interventions used, 66% of respondents reported using sauna therapy. Of the conditions treated, over 80 percent of practitioners use sauna-based detoxification for "general cleansing/preventive medicine." This protocol will utilize a sauna as the primary method of detoxification.
Previous studies on hyperthermia-based protocols for detoxification have been methodologically challenged and are not readily reproducible. Furthermore, there are no studies in the literature that identify how long of a protocol is tolerated, is feasible in the general population, or how long is needed to observe PCB (or other pollutant reduction). Therefore, we will employ a "high-dose" protocol and a "low-dose" protocol, based on ranges reported in the literature, in order to evaluate dose-finding outcomes to hyperthermia, including tolerability, retention, and participant-reported outcomes.
High Dose Participants randomized to this group will undergo a protocol consisting of 2 hours of sauna therapy per day, for a minimum of 5 days per week, completed in 3 weeks or less (21 days). (15 total sessions, 30 hours of sauna). Participants will be able to schedule visits on any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in which days are attended will be utilized to increase likelihood of retention. A participant may attend visits for 15 consecutive days, should they wish.
Low Dose Participants randomized to this group will undergo a protocol consisting of 1 hour of sauna therapy per day, for a minimum of 3 days per week, completed in 3 weeks or less (21 days). (9 total sessions, 9 hours of sauna). Participants will be able to schedule visits on any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in which days are attended will be utilized to increase likelihood of retention. Participants will be able to attend 9 consecutive sessions, should they wish.
- Conditions
- Hyperthermia
- Being tested
- This protocol will utilize a sauna as the primary method of detoxification.
- Keywords
- Detoxification, Sauna
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This protocol will utilize a sauna as the primary method of detoxification.Other
This study is a randomized, 2-arm, dose-finding safety and feasibility trial. After screening, informed consent and randomization, participants will complete a medically-monitored sauna-based detoxification program.
High Dose Participants randomized to this group will undergo a protocol consisting of 2 hours of sauna therapy per day, for a minimum of 5 days per week, completed in 3 weeks or less (21 days). (15 total sessions, 30 hours of sauna).
Low Dose Participants randomized to this group will undergo a protocol consisting of 1 hour of sauna therapy per day, for a minimum of 3 days per week, completed in 3 weeks or less (21 days). (9 total sessions, 9 hours of sauna).
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Active comparator | Participants randomized to this group will undergo a protocol consisting of 1 hour of sauna therapy per day, for a minimum of 3 days per week, completed in 3 weeks or less (21 days). (9 total sessions, 9 hours of sauna). Participants will be able to schedule visits on any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in which days are attended will be utilized to increase likelihood of retention. Participants will be able to attend 9 consecutive sessions, should they wish. Receives: Other: This protocol will utilize a sauna as the primary method of detoxification. |
| High Dose | Active comparator | Participants randomized to this group will undergo a protocol consisting of 2 hours of sauna therapy per day, for a minimum of 5 days per week, completed in 3 weeks or less (21 days). (15 total sessions, 30 hours of sauna). Participants will be able to schedule visits on any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in which days are attended will be utilized to increase likelihood of retention. A participant may attend visits for 15 consecutive days, should they wish. Receives: Other: This protocol will utilize a sauna as the primary method of detoxification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment/Retention
Assess recruitment/retention goals/milestones
Measured: Up to 6 months
Protocol adherence
Assess protocol adherence
Measured: Up to 6 months
Change from baseline in Clinical Chemistry Panel
Complete metabolic panel, within normal limit (y/n)?
Measured: Baseline and 4 weeks
AE Monitoring
Adverse event monitoring tool: FDA Monitoring of Side Effects System (MOSES)
Measured: Up to 6 months
Vital signs
Vital signs within normal limits (y/n)?
Measured: Up to 6 months
Participant-reported outcome questionnaire
NIH PROMIS Questionnaire
Measured: Baseline and up to 4 weeks
Short Form 36 health survey
Health survey questionnaire
Measured: Basleine and up to 4 weeks
Secondary outcomes (1)
Polychlorinated biphenyls
Measure serum concentrations of PCBs
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionApr 2012
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 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, N.D., MPH, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576822
- Sponsor's protocol ID
- H35B11
- Other IDs
- 4R00AT004711-03
- Status last verified
- Oct 2012
- First submitted
- 1 Feb 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary and Alternative Medicine Detoxification: Safety and Efficacy
- ClinicalTrials.gov ID
- NCT01576822
- Acronym / sponsor ID
- H35B11
- Conditions
- Hyperthermia
- Keywords
- Detoxification, Sauna
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 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
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Apr 2012 (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 goal of this study is to assess the feasibility of the approach, conduct a dose-finding investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials in the assessment of human chemical body burden reduction, for general wellness, detoxification, and pain reduction.
The investigators wish to determine if a hyperthermia-based detoxification protocol is feasible to conduct: including assessment of recruitment, enrollment, retention, protocol adherence, adverse events, and changes in serum polychlorinated biphenyls (PCBs).
Detailed description
According to our nationwide survey of Naturopathic Physicians regarding use of detoxification, approximately 80 percent of NDs (Naturopathic Doctors) use some type of detoxification interventions in clinical practice on a regular basis. Of the interventions used, 66% of respondents reported using sauna therapy. Of the conditions treated, over 80 percent of practitioners use sauna-based detoxification for "general cleansing/preventive medicine." This protocol will utilize a sauna as the primary method of detoxification.
Previous studies on hyperthermia-based protocols for detoxification have been methodologically challenged and are not readily reproducible. Furthermore, there are no studies in the literature that identify how long of a protocol is tolerated, is feasible in the general population, or how long is needed to observe PCB (or other pollutant reduction). Therefore, we will employ a "high-dose" protocol and a "low-dose" protocol, based on ranges reported in the literature, in order to evaluate dose-finding outcomes to hyperthermia, including tolerability, retention, and participant-reported outcomes.
High Dose Participants randomized to this group will undergo a protocol consisting of 2 hours of sauna therapy per day, for a minimum of 5 days per week, completed in 3 weeks or less (21 days). (15 total sessions, 30 hours of sauna). Participants will be able to schedule visits on any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in which days are attended will be utilized to increase likelihood of retention. A participant may attend visits for 15 consecutive days, should they wish.
Low Dose Participants randomized to this group will undergo a protocol consisting of 1 hour of sauna therapy per day, for a minimum of 3 days per week, completed in 3 weeks or less (21 days). (9 total sessions, 9 hours of sauna). Participants will be able to schedule visits on any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in which days are attended will be utilized to increase likelihood of retention. Participants will be able to attend 9 consecutive sessions, should they wish.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Active comparator | Other: This protocol will utilize a sauna as the primary method of detoxification.Participants randomized to this group will undergo a protocol consisting of 1 hour of sauna therapy per day, for a minimum of 3 days per week, completed in 3 weeks or less (21 days). (9 total sessions, 9 hours of sauna). Participants will be able to schedule visits on any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in which days are attended will be utilized to increase likelihood of retention. Participants will be able to attend 9 consecutive sessions, should they wish. |
| High Dose | Active comparator | Other: This protocol will utilize a sauna as the primary method of detoxification.Participants randomized to this group will undergo a protocol consisting of 2 hours of sauna therapy per day, for a minimum of 5 days per week, completed in 3 weeks or less (21 days). (15 total sessions, 30 hours of sauna). Participants will be able to schedule visits on any of 7 days per week. Maximum flexibility in hours of operation as well as flexibility in which days are attended will be utilized to increase likelihood of retention. A participant may attend visits for 15 consecutive days, should they wish. |
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 30 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 IUD (non- hormone)) throughout the study and take a pregnancy test at screening, and weekly during the study.
Key exclusion criteria (8 listed)
- Pregnant, or trying to become pregnant in the three months following screening.
- Current use of any prescribed pharmaceutical medications (including oral contraceptive pills, without additional barrier contraception).
- Participants who have a BMI greater than 30 kg/m2, elevated fasting blood sugar, bradycardia, hyper or hypotension or evidence of a medical condition.
- A 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.
- Clinical chemistry lab values outside of reference lab normal ranges (except in cases of ranges within 10% ULN and isolated measurements in the absence of chronic disease).
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 |
|---|---|---|
| This protocol will utilize a sauna as the primary method of detoxification.This study is a randomized, 2-arm, dose-finding safety and feasibility trial. After screening, informed consent and randomization, participants will complete a medically-monitored sauna-based detoxification program. High Dose Participants randomized to this group will undergo a protocol consisting of 2 hours of sauna therapy per day, for a minimum of 5 days per week, completed in 3 weeks or less (21 days). (15 total sessions, 30 hours of sauna). Low Dose Participants randomized to this group will undergo a protocol consisting of 1 hour of sauna therapy per day, for a minimum of 3 days per week, completed in 3 weeks or less (21 days). (9 total sessions, 9 hours of sauna). | Other | High Dose, Low Dose |
Primary outcome
Recruitment/Retention
Time frame: Up to 6 months
Assess recruitment/retention goals/milestones
Protocol adherence
Time frame: Up to 6 months
Assess protocol adherence
Change from baseline in Clinical Chemistry Panel
Time frame: Baseline and 4 weeks
Complete metabolic panel, within normal limit (y/n)?
AE Monitoring
Time frame: Up to 6 months
Adverse event monitoring tool: FDA Monitoring of Side Effects System (MOSES)
Vital signs
Time frame: Up to 6 months
Vital signs within normal limits (y/n)?
Participant-reported outcome questionnaire
Time frame: Baseline and up to 4 weeks
NIH PROMIS Questionnaire
Short Form 36 health survey
Time frame: Basleine and up to 4 weeks
Health survey questionnaire
1 secondary outcome
Polychlorinated biphenyls
Time frame: Baseline and 4 weeks
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 30 Oct 2012.
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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, N.D., MPH principal investigator
Bastyr University
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 This protocol will utilize a sauna as the primary method of detoxification. 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 8 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 30 Oct 2012. 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 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?
Recruitment/Retention (time frame: Up to 6 months). The study lists 7 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 30 Oct 2012.