Hyperthermia Safety Study Uses Temperature Management System to Gently Raise Participant's Body Temperature to a Fever-range Level in a Controlled Setting. (BTT)
29. April 2026 aktualisiert von: Marc Abreu
Clinical and Biological Safety Study of the BTT Hyperthermia in Adult Subjects
The Abreu BTT 700 Temperature Management System (TMS) is a device that gently raises the body temperature of the participant to a fever-range level in a controlled setting.
There will be one study treatment session.
with the TMS system and four safety assessments: before the session, about two hours afterward, on the next day, and again on the third day after the session.
Your participation in the study will last about three days in total.
An electrocardiogram (ECG - traces the electrical activity of the heart) will be performed during screening.
This is not a randomized or blinded study -- all participants will receive the same study treatment.
The TMS system has been previously used in other settings, but this study is designed specifically to collect safety data in adult volunteers.
Studienübersicht
Status
Anmeldung auf Einladung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Participants are being asked to take part because they are healthy adults between the ages of 18 and 65 and have no history of any heart, cancer, or neurological disorders. Participation in this study will help researchers understand how healthy people respond to this technology before it is tested in people with specific medical conditions.
Voluntary Participation: Taking part in this study is completely voluntary. Volunteers do not have to participate and may withdraw at any time. Stopping to participate in the study will not result in any penalties or loss of benefits.
Benefits, Compensation, and Risk: Subjects may not receive any direct benefit from participating in this study. However, participation will help researchers develop safer treatments for others in the future. There is no cost to participate.
Possible risks include feeling tired, sweating, or experiencing temporary changes in heart rate or blood pressure. Rare but serious risks could include overheating, dehydration, or fainting. The study team will monitor you closely throughout the process to minimize risks and will stop the session immediately if there are any safety concerns.
Studientyp
Interventionell
Einschreibung (Geschätzt)
20
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Florida
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Aventura, Florida, Vereinigte Staaten, 33160
- BTT Medical Institute LLC
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- A person who meets all of the following criteria will be eligible for this study:
Provision of signed and dated informed consent/assent form.
- Ability to understand the nature of the study and protocol requirements and provide written informed consent.
- Willingness to comply with all study procedures and availability for the duration of the study.
- Aged over 18 years and no more than 65 years
- Males and Female
Values of vital signs before BTT Hyperthermic Induction should be:
- Systolic between 100-140 mm Hg o diastolic between 50-90 mm Hg
- cardiac pulse between 45-90 beats per minute
- Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatory drugs)
Exclusion Criteria:
History of Cardiovascular and venous thrombosis disorders
- History of auto-immune disorders
- History of pulmonary disease
- History of Neurological disorders
- History of Cancer disorders
- Renal or Hepatic insufficiency
- Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects who do not support high fever range in the past during adult or childhood life.
- Pathology evolutionary time of the review of inclusion
- Excessive consumption of alcohol, tobacco (over 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse.
The person(s) with the following condition(s) are excluded to participate in the study
- Implanted electronic devices
- Any metal implant
- Dermatological conditions sensitive to heat
- Any enclosed infection that, as assessed by a qualified physician, serves as a contraindication for hyperthermia
- Clinically significant ECG findings, as per determined by a cardiologist, including uncontrolled arrhythmia
- A subject who in the opinion of the Principal Investigator would not be able to safely complete the study
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Single Arm with one hyperthermia treatment
one hyperthermia treatment
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controlled induced hyperthermia
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: Baseline (pre-treatment) through post-treatment (48-hours post treatment)
|
Incidence, type, and severity of treatment-emergent adverse events following whole-body hyperthermia (WBH).
|
Baseline (pre-treatment) through post-treatment (48-hours post treatment)
|
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Change in Cardiovascular Vital Signs (Heart Rate)
Zeitfenster: Baseline (pre-treatment) through post-treatment (48-hours post treatment)
|
|
Baseline (pre-treatment) through post-treatment (48-hours post treatment)
|
|
Change in Cardiovascular Vital Signs (Blood Pressure)
Zeitfenster: Baseline (pre-treatment) through post-treatment (48-hours post treatment)]
|
Change from baseline in blood pressure. Parameters: Systolic/diastolic blood pressure (mmHg) Unit of Measure: Absolute values and change from baseline Measurement Tool: Automated vital signs monitor |
Baseline (pre-treatment) through post-treatment (48-hours post treatment)]
|
|
Change in Comprehensive Metabolic Panel Renal Function Markers (Creatinine)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Change in Comprehensive Metabolic Panel Renal Function (BUN)
Zeitfenster: Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
|
|
Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
|
|
Change in Comprehensive Metabolic Panel Renal Function (eGFR)
Zeitfenster: Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
|
Change from baseline in renal function markers. (eGFR)
|
Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
|
|
Change in Comprehensive Metabolic Panel Hepatic Function (AST)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change from baseline in Hepatic function markers. (AST)
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Change in Comprehensive Metabolic Panel Hepatic Function (ALT)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change from baseline in Hepatic function markers. (ALT)
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Change in Comprehensive Metabolic Panel Hepatic Function (ALP)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change from baseline in Hepatic function markers. (ALP)
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Change in Comprehensive Metabolic Panel Hepatic Function (Total Bilirubin)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change from baseline in Hepatic function markers. (Total Bilirubin)
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Change in Comprehensive Metabolic Panel Hepatic Function (GGT)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change from baseline in Hepatic function markers. (GGT) • Parameters: GGT (U/L) Unit of Measure: Absolute values and change from baseline • Measurement Tool: Clinical chemistry analyzer (Comprehensive Metabolic Panel) |
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Change in Hematologic Parameters (CBC- White Blood Cell Count)
Zeitfenster: Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
|
|
Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
|
|
Change in Hematologic Parameters (CBC- Hemoglobin)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change in Hematologic Parameters (CBC- Hemoglobin) Change from baseline in hematologic indices.
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
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Change in Hematologic Parameters (CBC- Hematocrit)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Change from baseline in hematologic indices.
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Change in Hematologic Parameters (CBC- Platelet Count)
Zeitfenster: Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
|
Change from baseline in hematologic indices.
|
Baseline (pre-treatment), post-treatment ( 24hrs. and 48-hours post treatment)
|
|
Change in Hematologic Parameters (CBC- Erythrocyte Sedimentation Rate)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Change in Hematologic Parameters (C-Reactive Protein)
Zeitfenster: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Respiratory Parameters (Respiratory Rate)
Zeitfenster: Pretreatment through 48hrs. after the treatment
|
|
Pretreatment through 48hrs. after the treatment
|
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Change in Respiratory Parameters (Oxygen Saturation)
Zeitfenster: Pretreatment through 48hrs. after the treatment
|
Change from baseline in oxygen Saturation.
|
Pretreatment through 48hrs. after the treatment
|
|
Change in Pulmonary Function (FEV1)
Zeitfenster: Pretreatment and 48hrs. after the treatment
|
|
Pretreatment and 48hrs. after the treatment
|
|
Change in Pulmonary Function (FVC)
Zeitfenster: Pretreatment and 48hrs. after the treatment
|
Change from baseline in pulmonary performance.
Unit of Measure: Standard spirometry parameters FVC (liters) Measurement Tool: Spirometer
|
Pretreatment and 48hrs. after the treatment
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Marcio Abreu, MD, BTT Medical Institute
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Mason AE, Fisher SM, Chowdhary A, Guvva E, Veasna D, Floyd E, Fender SB, Raison C. Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Int J Hyperthermia. 2021;38(1):1529-1535. doi: 10.1080/02656736.2021.1991010.
- Zschaeck S, Weingartner J, Ghadjar P, Wust P, Mehrhof F, Kalinauskaite G, Ehrhardt VH, Hartmann V, Tinhofer I, Heiland M, Coordes A, Kofla G, Budach V, Stromberger C, Beck M. Fever range whole body hyperthermia for re-irradiation of head and neck squamous cell carcinomas: Final results of a prospective study. Oral Oncol. 2021 May;116:105240. doi: 10.1016/j.oraloncology.2021.105240. Epub 2021 Feb 21.
- Oehler R, Pusch E, Zellner M, Dungel P, Hergovics N, Homoncik M, Eliasen MM, Brabec M, Roth E. Cell type-specific variations in the induction of hsp70 in human leukocytes by feverlike whole body hyperthermia. Cell Stress Chaperones. 2001 Oct;6(4):306-15. doi: 10.1379/1466-1268(2001)0062.0.co;2.
- Brazaitis M, Eimantas N, Baranauskiene N, Kilikeviciene S, Vitkauskiene A, Daniuseviciute L. Effects of severe whole-body hyperthermia on ovarian hormone and extracellular Hsp72 responses in young adult women. Int J Hyperthermia. 2019;36(1):660-665. doi: 10.1080/02656736.2019.1627431.
- Evans SS, Repasky EA, Fisher DT. Fever and the thermal regulation of immunity: the immune system feels the heat. Nat Rev Immunol. 2015 Jun;15(6):335-49. doi: 10.1038/nri3843. Epub 2015 May 15.
- Zauner D, Quehenberger F, Hermann J, Dejaco C, Stradner MH, Stojakovic T, Angerer H, Rinner B, Graninger WB. Whole body hyperthermia treatment increases interleukin 10 and toll-like receptor 4 expression in patients with ankylosing spondylitis: a pilot study. Int J Hyperthermia. 2014 Sep;30(6):393-401. doi: 10.3109/02656736.2014.956810.
- Mason AE, Chowdhary A, Hartogensis W, Siwik CJ, Lupesko-Persky O, Pandya LS, Roberts S, Anglo C, Moran PJ, Nelson JC, Lowry CA, Patrick RP, Raison CL, Hecht FM. Feasibility and acceptability of an integrated mind-body intervention for depression: whole-body hyperthermia (WBH) and cognitive behavioral therapy (CBT). Int J Hyperthermia. 2024;41(1):2351459. doi: 10.1080/02656736.2024.2351459. Epub 2024 May 14.
- Mason AE, Hartogensis W, Chowdhary A, Siwik CJ, Pandya LS, Jung E, Lupesko-Persky O, Hartley E, Hopkins L, Roberts S, Borovinsky J, Nelson JC, Lowry CA, Patrick RP, Moran PJ, Raison CL, Hecht FM. A Randomized Trial Testing a Novel Mind and Body Intervention for Depression: Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH). Glob Adv Integr Med Health. 2025 Oct 22;14:27536130251387714. doi: 10.1177/27536130251387714. eCollection 2025 Jan-Dec.
- Hanusch KU, Janssen CW. The impact of whole-body hyperthermia interventions on mood and depression - are we ready for recommendations for clinical application? Int J Hyperthermia. 2019;36(1):573-581. doi: 10.1080/02656736.2019.1612103.
- https://clinicaltrials.gov/ct2/show/NCT03906149?term=Depression&cond=Hyperthermia&cntry=DE&city=Essen&rank=1 Whole-body Hyperthermia for Moderate to Severe Depressive Disorder (HYPE2)
- https://classic.clinicaltrials.gov/ct2/show/NCT05366270?term=simmie+foster&cond=Depression&cntry=US&draw=2&rank=1 Massachusetts General Hospital Boston / USA Peripheral Neuroimmune Mechanisms of Hyperthermia
- https://clinicaltrials.gov/ct2/show/NCT05821166 Charite University Berlin, Department of Radiation Oncology and Radiotherapy Potential of Moderate Whole Body Hyperthermia to Enhance Response (POWER)
- Knobel A, Hanusch K, Auen N, Rübener F, Fischer S, Borzim C, Heinz A, Schäfer M: Whole-Body Hyperthermia (WBH) in Psychiatry In: Water-filtered Infrared A (wIRA) Irradiation (Ed.: P. Vaupel), pp. 155-164. Springer Nature Switzerland, Cham. DOI: 10.1007/978-3-030-92880-3_12 OPEN ACCESS https://link.springer.com/content/pdf/10.1007%2F978-3-030-92880-3_12
- Naumann J, Grebe J, Kaifel S, Weinert T, Sadaghiani C, Huber R. Effects of hyperthermic baths on depression, sleep and heart rate variability in patients with depressive disorder: a randomized clinical pilot trial. BMC Complement Altern Med. 2017 Mar 28;17(1):172. doi: 10.1186/s12906-017-1676-5.
- Flux MC, Smith DG, Allen JJB, Mehl MR, Medrano A, Begay TK, Middlemist BH, Marquart BM, Cole SP, Sauder CJ, Lowry CA, Raison CL. Association of plasma cytokines and antidepressant response following mild-intensity whole-body hyperthermia in major depressive disorder. Transl Psychiatry. 2023 Apr 21;13(1):132. doi: 10.1038/s41398-023-02402-9.
- Brancato L, Gorbaslieva I, Rudenko O, Logghe T, van Zwol E, Boulet G, Van den Bossche L, Van den Bossche J, Peeters M, Chapelle T, Saldien V, Vueghs P, Vandamme T, Dankerlui R, Ysebaert D, Bogers J. The MATTERS Trial: Safety and Tolerability of Whole-Body Hyperthermia at 41.50 degrees C in Combination with Chemotherapy in Metastatic Cancer Patients. Cancer Res Commun. 2026 Feb 1;6(2):273-283. doi: 10.1158/2767-9764.CRC-25-0660.
- Broomand MA, Kalantari Khandani M, Sandoughdaran S, Mirzaei H. Systemic Hyperthermia Combined with Chemotherapy: A Pilot Clinical Trial in the Treatment of Metastatic Gastrointestinal Cancers. Int J Cancer Manag. 2025;18(1):e159729. doi: https://doi.org/10.5812/ijcm-159729
- Kobayashi Y, Ito Y, Ostapenko VV, Sakai M, Matsushita N, Imai K, Shimizu K, Aruga A, Tanigawa K. Fever-range whole-body heat treatment stimulates antigen-specific T-cell responses in humans. Immunol Lett. 2014 Nov;162(1 Pt A):256-61. doi: 10.1016/j.imlet.2014.09.014. Epub 2014 Sep 26.
- Hohneck AL, Sadikaj L, Heinemann L, Schroeder M, Riess H, Gerhards A, Burkholder I, Heckel-Reusser S, Gottfried J, Hofheinz RD. Patients with Advanced Pancreatic Cancer Treated with Mistletoe and Hyperthermia in Addition to Palliative Chemotherapy: A Retrospective Single-Center Analysis. Cancers (Basel). 2023 Oct 11;15(20):4929. doi: 10.3390/cancers15204929.
- Faghihi Moghaddam F, Bakhshandeh M, Mofid B, Sahinbas H, Faeghi F, Mirzaei H, Rakhsha A, Yousefi Kashi AS, Sadeghi R, Mahdavi A. Clinical effectiveness of combined whole body hyperthermia and external beam radiation therapy (EBRT) versus EBRT alone in patients with painful bony metastases: A phase III clinical trial study. J Therm Biol. 2024 Feb;120:103804. doi: 10.1016/j.jtherbio.2024.103804. Epub 2024 Feb 23.
- Liu P, Wu J, Chen L, Wu Z, Wu Y, Zhang G, Yu B, Zhang B, Wei N, Shi J, Zhang C, Lei L, Yu S, Lai J, Guo Z, Zheng Y, Jing Z, Jiang H, Wang T, Zhou J, Wu Y, Sun C, Shen J, Zhang J, Wu Z. Water-filtered infrared A radiation hyperthermia combined with immunotherapy for advanced gastrointestinal tumours. Cancer Med. 2024 Jul;13(14):e70024. doi: 10.1002/cam4.70024.
- Kockelmann F, Giger-Pabst U, Ouaissi M, Bucur P, Barbey S, VON Ardenne A, Zieren J. First Clinical Safety and Feasibility Data of Whole-body Hyperthermia Pressurized Intraperitoneal Aerosol Chemotherapy (WBH-PIPAC) for Peritoneal Surface Malignancies. Anticancer Res. 2024 Jul;44(7):3043-3050. doi: 10.21873/anticanres.17117.
- Liebl CM, Kutschan S, Dorfler J, Kasmann L, Hubner J. Systematic review about complementary medical hyperthermia in oncology. Clin Exp Med. 2022 Nov;22(4):519-565. doi: 10.1007/s10238-022-00846-9. Epub 2022 Jun 29.
- Vertree RA, Leeth A, Girouard M, Roach JD, Zwischenberger JB. Whole-body hyperthermia: a review of theory, design and application. Perfusion. 2002 Jul;17(4):279-90. doi: 10.1191/0267659102pf588oa.
- Kraybill WG, Olenki T, Evans SS, Ostberg JR, O'Leary KA, Gibbs JF, Repasky EA. A phase I study of fever-range whole body hyperthermia (FR-WBH) in patients with advanced solid tumours: correlation with mouse models. Int J Hyperthermia. 2002 May-Jun;18(3):253-66. doi: 10.1080/02656730110116704.
- Hohneck AL, Schmitz-Solheid V, Gencer D, Schroeder M, Riess H, Gerhards A, Burkholder I, Heckel-Reusser S, Gottfried J, Hofheinz RD. Predictors of Successful Whole-Body Hyperthermia in Cancer Patients: Target Temperature Achievement and Safety Analysis. Cancers (Basel). 2025 Aug 21;17(16):2716. doi: 10.3390/cancers17162716.
- Smadja DM, Abreu MM. Hyperthermia and targeting heat shock proteins: innovative approaches for neurodegenerative disorders and Long COVID. Front Neurosci. 2025 Feb 4;19:1475376. doi: 10.3389/fnins.2025.1475376. eCollection 2025.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Mai 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2026
Studienabschluss (Geschätzt)
1. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
17. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. April 2026
Zuerst gepostet (Tatsächlich)
4. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BTT 25-001 SS
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