Clinical trial NCT01576822: Sauna Detoxification Study: Pilot Feasibility
Official title: Complementary and Alternative Medicine Detoxification: Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperthermia
Keywords: Detoxification
Sauna
Lead sponsor: Bastyr University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2012-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Recruitment/Retention
timeFrame: Up to 6 months
measure: Protocol adherence
timeFrame: Up to 6 months
measure: Change from baseline in Clinical Chemistry Panel
timeFrame: Baseline and 4 weeks
measure: AE Monitoring
timeFrame: Up to 6 months
measure: Vital signs
timeFrame: Up to 6 months
measure: Participant-reported outcome questionnaire
timeFrame: Baseline and up to 4 weeks
measure: Short Form 36 health survey
timeFrame: Basleine and up to 4 weeks
Secondary outcomes:
measure: Polychlorinated biphenyls
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University Clinical Research Center
state: Washington
Study officials:
affiliation: Bastyr University
name: Jason Allen, N.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: