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 de abril de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Florida
-
Aventura, Florida, Estados Unidos, 33160
- BTT Medical Institute LLC
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Single Arm with one hyperthermia treatment
one hyperthermia treatment
|
controlled induced hyperthermia
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: 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)
|
|
Change in Cardiovascular Vital Signs (Heart Rate)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
|
Change in Hematologic Parameters (CBC- Hematocrit)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Respiratory Parameters (Respiratory Rate)
Periodo de tiempo: Pretreatment through 48hrs. after the treatment
|
|
Pretreatment through 48hrs. after the treatment
|
|
Change in Respiratory Parameters (Oxygen Saturation)
Periodo de tiempo: Pretreatment through 48hrs. after the treatment
|
Change from baseline in oxygen Saturation.
|
Pretreatment through 48hrs. after the treatment
|
|
Change in Pulmonary Function (FEV1)
Periodo de tiempo: Pretreatment and 48hrs. after the treatment
|
|
Pretreatment and 48hrs. after the treatment
|
|
Change in Pulmonary Function (FVC)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Marcio Abreu, MD, BTT Medical Institute
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de mayo de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
17 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
4 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BTT 25-001 SS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .