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. dubna 2026 aktualizováno: 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.
Přehled studie
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
20
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Florida
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Aventura, Florida, Spojené státy, 33160
- BTT Medical Institute LLC
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Single Arm with one hyperthermia treatment
one hyperthermia treatment
|
controlled induced hyperthermia
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Respiratory Parameters (Respiratory Rate)
Časové okno: Pretreatment through 48hrs. after the treatment
|
|
Pretreatment through 48hrs. after the treatment
|
|
Change in Respiratory Parameters (Oxygen Saturation)
Časové okno: Pretreatment through 48hrs. after the treatment
|
Change from baseline in oxygen Saturation.
|
Pretreatment through 48hrs. after the treatment
|
|
Change in Pulmonary Function (FEV1)
Časové okno: Pretreatment and 48hrs. after the treatment
|
|
Pretreatment and 48hrs. after the treatment
|
|
Change in Pulmonary Function (FVC)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Marcio Abreu, MD, BTT Medical Institute
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. května 2026
Primární dokončení (Odhadovaný)
1. prosince 2026
Dokončení studie (Odhadovaný)
1. prosince 2026
Termíny zápisu do studia
První předloženo
17. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
29. dubna 2026
První zveřejněno (Aktuální)
4. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
29. dubna 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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Studuje lékový produkt regulovaný americkým FDA
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produkt vyrobený a vyvážený z USA
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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