Sauna Detoxification Study: Pilot Feasibility

NCT01576822 | Completed Phase 1 DMC

• 2 other identifiers: H35B114R00AT004711-03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Hyperthermia

Keywords

Detoxification; Sauna

Outcome Measures

Primary Outcomes (7)

• Recruitment/Retention

  Assess recruitment/retention goals/milestones

  Up to 6 months

• Protocol adherence

  Assess protocol adherence

  Up to 6 months

• Change from baseline in Clinical Chemistry Panel

  Complete metabolic panel, within normal limit (y/n)?

  Baseline and 4 weeks

• AE Monitoring

  Adverse event monitoring tool: FDA Monitoring of Side Effects System (MOSES)

  Up to 6 months

• Vital signs

  Vital signs within normal limits (y/n)?

  Up to 6 months

• Participant-reported outcome questionnaire

  NIH PROMIS Questionnaire

  Baseline and up to 4 weeks

• Short Form 36 health survey

  Health survey questionnaire

  Basleine and up to 4 weeks

Secondary Outcomes (1)

• Polychlorinated biphenyls

  Baseline and 4 weeks

Study Arms (2)

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.

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.

Other: This protocol will utilize a sauna as the primary method of detoxification.

Interventions

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).

High Dose; Low Dose

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bastyr University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Bastyr University Clinical Research Center

Kenmore, Washington, 98028, United States

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Jason Allen, N.D., MPH

  Bastyr University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: April 13, 2012
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

US (1)