Sauna Detoxification Study: Pilot Feasibility

Hyperthermia Clinical Trial

Official title:

Complementary and Alternative Medicine Detoxification: Safety and Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576822
• Other study ID #: H35B11
• Secondary ID: 4R00AT004711-03
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2012
• Last updated: October 29, 2012
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board (IRB)
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 35 Years

Eligibility

Inclusion Criteria:

1. 21-35 years.

2. Body mass index (BMI) 19 to 30 kg/m2 at the screening evaluation.

3. Ability to schedule and attend daily visits for the duration of the study.

4. 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.

Exclusion Criteria:

1. Pregnant, or trying to become pregnant in the three months following screening.

2. Current use of any prescribed pharmaceutical medications (including oral contraceptive pills, without additional barrier contraception).

3. Participants who have a BMI greater than 30 kg/m2, elevated fasting blood sugar, bradycardia, hyper or hypotension or evidence of a medical condition.

4. 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.

5. 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).

6. Recent infection (<14 days), open sores, or communicable skin conditions.

7. Current use of any tobacco products or illicit drugs.

8. 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fever
• Hyperthermia

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United States	Bastyr University Clinical Research Center	Kenmore	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Bastyr University	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment/Retention	Assess recruitment/retention goals/milestones	Up to 6 months	No
Primary	Protocol adherence	Assess protocol adherence	Up to 6 months	No
Primary	Change from baseline in Clinical Chemistry Panel	Complete metabolic panel, within normal limit (y/n)?	Baseline and 4 weeks	Yes
Primary	AE Monitoring	Adverse event monitoring tool: FDA Monitoring of Side Effects System (MOSES)	Up to 6 months	Yes
Primary	Vital signs	Vital signs within normal limits (y/n)?	Up to 6 months	Yes
Primary	Participant-reported outcome questionnaire	NIH PROMIS Questionnaire	Baseline and up to 4 weeks	No
Primary	Short Form 36 health survey	Health survey questionnaire	Basleine and up to 4 weeks	No
Secondary	Polychlorinated biphenyls	Measure serum concentrations of PCBs	Baseline and 4 weeks	No