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Sauna Detoxification Study: Pilot Feasibility

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Bastyr University
ClinicalTrials.gov Identifier:
NCT01576822
First received: February 1, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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).


Condition Intervention Phase
Hyperthermia
Other: This protocol will utilize a sauna as the primary method of detoxification.
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Complementary and Alternative Medicine Detoxification: Safety and Efficacy

Resource links provided by NLM:


Further study details as provided by Bastyr University:

Primary Outcome Measures:
  • Recruitment/Retention [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Assess recruitment/retention goals/milestones

  • Protocol adherence [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Assess protocol adherence

  • Change from baseline in Clinical Chemistry Panel [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]
    Complete metabolic panel, within normal limit (y/n)?

  • AE Monitoring [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Adverse event monitoring tool: FDA Monitoring of Side Effects System (MOSES)

  • Vital signs [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Vital signs within normal limits (y/n)?

  • Participant-reported outcome questionnaire [ Time Frame: Baseline and up to 4 weeks ] [ Designated as safety issue: No ]
    NIH PROMIS Questionnaire

  • Short Form 36 health survey [ Time Frame: Basleine and up to 4 weeks ] [ Designated as safety issue: No ]
    Health survey questionnaire


Secondary Outcome Measures:
  • Polychlorinated biphenyls [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    Measure serum concentrations of PCBs


Enrollment: 10
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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).

Active Comparator: 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.
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).


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

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576822

Locations
United States, Washington
Bastyr University Clinical Research Center
Kenmore, Washington, United States, 98028
Sponsors and Collaborators
Bastyr University
Investigators
Principal Investigator: Jason Allen, N.D., MPH Bastyr University
  More Information

No publications provided

Responsible Party: Bastyr University
ClinicalTrials.gov Identifier: NCT01576822     History of Changes
Other Study ID Numbers: H35B11, 4R00AT004711-03
Study First Received: February 1, 2012
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board (IRB)

Keywords provided by Bastyr University:
Detoxification
Sauna

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014