Hyperthermia Safety Study Uses Temperature Management System to Gently Raise Participant's Body Temperature to a Fever-range Level in a Controlled Setting. (BTT)
2026年4月29日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Florida
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Aventura、Florida、美国、33160
- BTT Medical Institute LLC
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Single Arm with one hyperthermia treatment
one hyperthermia treatment
|
controlled induced hyperthermia
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
|
Baseline (pre-treatment), post-treatment (24hrs. and 48-hours post treatment)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Respiratory Parameters (Respiratory Rate)
大体时间：Pretreatment through 48hrs. after the treatment
|
|
Pretreatment through 48hrs. after the treatment
|
|
Change in Respiratory Parameters (Oxygen Saturation)
大体时间：Pretreatment through 48hrs. after the treatment
|
Change from baseline in oxygen Saturation.
|
Pretreatment through 48hrs. after the treatment
|
|
Change in Pulmonary Function (FEV1)
大体时间：Pretreatment and 48hrs. after the treatment
|
|
Pretreatment and 48hrs. after the treatment
|
|
Change in Pulmonary Function (FVC)
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Marcio Abreu, MD、BTT Medical Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月1日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年4月17日
首先提交符合 QC 标准的
2026年4月29日
首次发布 (实际的)
2026年5月4日
研究记录更新
最后更新发布 (实际的)
2026年5月4日
上次提交的符合 QC 标准的更新
2026年4月29日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.