HIPECHIPECNCT05426928
Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC
An observational study of HIPEC, run by Henry Ford Health System at 1 site in United States.
Trial summary
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a well-established alternative for patients with peritoneal surface malignancies. Although HIPEC has a predetermined protocol to manage body temperature, the resultant bladder and core-body temperatures are highly variable and unstable in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIPEC
- What is being tested?
- Additional temperature monitoring/recording
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of all patients who are scheduled to undergo hyperthermic intraperitoneal chemotherapy (HIPEC) for abdominal cancer at Henry Ford Main Hospital
Who may be able to join
- Adults (at least 18 years or older)
- Scheduled to undergo HIPEC surgery for abdominal cancer at HFH-Main
Who cannot join
- Pregnant females
- Minors
- Disease not amenable for treatment with HIPEC after surgical examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Katherine Nowak
Detroit, Michigan, 48202
Katherine Nowak, PhD, 313-771-7128, knowak2@hfhs.org
Carlos Guerra, MD, cguerra1@hfhs.org
About this study
Official title: Development of a Computational, Thermodynamic Model of Intraabdominal Hyperthermia in Humans Undergoing HIPEC
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a well-established alternative for patients with peritoneal surface malignancies. Although HIPEC has a predetermined protocol to manage body temperature, the resultant bladder and core-body temperatures are highly variable and unstable in clinical practice. Such results highlight an incomplete understanding of the thermodynamic processes during HIPEC in humans.
Previous clinical and animal investigations have studied abdominal hyperthermia, but a full human model incorporating patient variables, heat delivery, and the impact of the circulatory system and anesthesia in HIPEC has not been established.
This project seeks to develop and validate a computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. It is hypothesized that by incorporating patient, anesthetic, and perfusion-related variables in a thermodynamic model, the temperatures inside and outside the abdomen during HIPEC can be predicted.
Read the detailed description
Peritoneal surface malignancies are a group of cancers arising from rare primary or common secondary tumors. Regardless of the etiology, the prognosis is poor and only a few therapies have shown promising results. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a well-established alternative for patients with these malignancies. Still, as many as 46% of patients recur early after treatment.
Although HIPEC has a predetermined protocol to manage body temperature, the resultant bladder and core-body temperatures are highly variable. Age, gender, body mass index, and type and duration of chemotherapy are key factors influencing the incidence and severity of bladder hyperthermia. While clinical and animal investigations have studied abdominal hyperthermia, a full human model incorporating patient variables, heat delivery, and the impact of the circulatory system and anesthesia in HIPEC has not been established.
To bridge this gap in knowledge, this project seeks to develop and validate a computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. It is hypothesized that by incorporating patient, anesthetic, and perfusion-related variables in a thermodynamic model, the temperatures inside and outside the abdomen during HIPEC can be predicted. By predicting temperature changes during HIPEC, clinicians can improve the safety and efficacy of therapeutic hyperthermia.
The hypothesis will be evaluated through two specific aims:
Specific aim 1: To develop a computational, thermodynamic model of intraabdominal hyperthermia for humans undergoing HIPEC. The rationale is that existing thermodynamic models are designed for non-anesthetized or hypothermic humans, implying the need of a new model with the conditions of a HIPEC treatment.
Specific aim 2: To validate our novel computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. Our rationale is that by using real-world data, the initial (SA1) computational model can be optimized and ultimately used to formulate individualized hyperthermia treatments.
- Conditions
- HIPEC
- Being tested
- Additional temperature monitoring/recording
- Keywords
- Predictive model, Intraabdominal hyperthermia, Thermodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional temperature monitoring/recordingOther
All patients in this study will receive the same standard of care treatment for their HIPEC procedure. The only difference will be the use of additional temperature probes to collect more robust data regarding intraabdominal temperature, and the prospective collection of actual boundary conditions of the system.
| Study group | Role | What they receive |
|---|---|---|
| HIPEC | Adults undergoing cytoreductive surgery and who are deemed eligible for HIPEC after surgical exploration in the operating theatre.
The patients will receive HIPEC according to routine practice, as defined by the surgical oncologist. Receives: Other: Additional temperature monitoring/recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core-body Temperature (Celsius)
Temperature values over time during a HIPEC treatment.
Measured: Duration of HIPEC procedure (2-4 hours)
Bladder temperature (Celsius)
Temperature values over time during a HIPEC treatment.
Measured: Duration of HIPEC procedure (2-4 hours)
Secondary outcomes (19)
Mean Temperature of the Skin (C)
Weighed calculation of the skin temperature values over time during a HIPEC treatment.
Measured: Duration of HIPEC procedure (2-4 hours)
Intrabdominal wall tissue temperature (Celsius)
Temperature values over time during a HIPEC treatment.
Measured: Duration of HIPEC procedure (2-4 hours)
Set Temperature (Celsius)
Temperature values over time during a HIPEC treatment
Measured: Duration of HIPEC procedure (2-4 hours)
Inflow Temperature (Celsius)
Temperature values over time during a HIPEC treatment
Measured: Duration of HIPEC procedure (2-4 hrs)
Outflow Temperature (Celsius)
Temperature values over time during a HIPEC treatment
Measured: Duration of HIPEC procedure (2-4 hours)
HIPEC Flow
Flow values (mL/min) over time during a HIPEC treatment
Measured: Duration of HIPEC procedure (2-4 hours)
Operating Room Temperature (Celsius)
Temperature values over time during a HIPEC treatment
Measured: Duration of HIPEC procedure (2-4 hours)
Underbody Blanket Temperature (Celsius)
Temperature values over time during a HIPEC treatment
Measured: Duration of HIPEC procedure (2-4 hours)
Convection Air Blanket Temperature (Celsius)
Temperature values over time during a HIPEC treatment
Measured: Duration of HIPEC procedure (2-4 hours)
Intrabdominal Cavity Volume (mL)
3D-lab post-processing of preoperative CT scans.
Measured: Preoperative, on average within 3 months prior to surgery.
Peritoneal Cavity Volume (mL)
3D-lab post-processing of preoperative CT scans.
Measured: Preoperative, on average within 3 months prior to surgery.
Abdominal Volume (mL)
3D-lab post-processing of preoperative CT scans.
Measured: Preoperative, on average within 3 months prior to surgery.
Blood Pressure (mmHg)
Blood pressure values over time during a HIPEC treatment.
Measured: Duration of HIPEC procedure (2-4 hours)
Heart Rate (beats/min)
Heart rate values over time during a HIPEC treatment.
Measured: Duration of HIPEC procedure (2-4 hours)
Cardiac Output (L/min)
Cardiac output values over time during a HIPEC treatment.
Measured: Duration of HIPEC procedure (2-4 hours)
Stroke Volume Variation (%)
Stroke volume variation values over time during a HIPEC treatment.
Measured: Duration of HIPEC procedure (2-4 hours)
Body fat percentage (%)
Determined by impedancemetry
Measured: Preoperative, obtained the day of surgery.
Weight (Kg)
Participant's weight
Measured: Preoperative, obtained the day of surgery.
Height (m)
Participant's height
Measured: Preoperative, obtained the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start22 Sep 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIPECStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos E. Guerra, Henry Ford Health System
- Investigators
- Carlos Guerra, MD, Principal investigator, Staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426928
- Sponsor's protocol ID
- 15538
- Acronym
- HIPEC
- Status last verified
- Oct 2025
- First submitted
- 6 Jun 2022
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loke DR, Helderman RFCPA, Rodermond HM, Tanis PJ, Streekstra GJ, Franken NAP, Oei AL, Crezee J, Kok HP. Demonstration of treatment planning software for hyperthermic intraperitoneal chemotherapy in a rat model. Int J Hyperthermia. 2021;38(1):38-54. doi: 10.1080/02656736.2020.1852324.
PubMed 33487083Ladhari T, Szafnicki K. Modelling of some aspects of a biomedical process: application to the treatment of digestive cancer (HIPEC). 3 Biotech. 2018 Apr;8(4):190. doi: 10.1007/s13205-018-1211-5. Epub 2018 Mar 20.
PubMed 29564201Stolwijk JA, Nadel ER, Wenger CB, Roberts MF. Development and application of a mathematical model of human thermoregulation. Arch Sci Physiol (Paris). 1973;27(3):303-10. No abstract available.
PubMed 4807388Severens NM, van Marken Lichtenbelt WD, Frijns AJ, Van Steenhoven AA, de Mol BA, Sessler DI. A model to predict patient temperature during cardiac surgery. Phys Med Biol. 2007 Sep 7;52(17):5131-45. doi: 10.1088/0031-9155/52/17/002. Epub 2007 Aug 7.
PubMed 17762076
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Computational, Thermodynamic Model of Intraabdominal Hyperthermia in Humans Undergoing HIPEC
- ClinicalTrials.gov ID
- NCT05426928
- Acronym / sponsor ID
- HIPEC / 15538
- Conditions
- HIPEC
- Keywords
- Predictive model, Intraabdominal hyperthermia, Thermodynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a well-established alternative for patients with peritoneal surface malignancies. Although HIPEC has a predetermined protocol to manage body temperature, the resultant bladder and core-body temperatures are highly variable and unstable in clinical practice. Such results highlight an incomplete understanding of the thermodynamic processes during HIPEC in humans.
Previous clinical and animal investigations have studied abdominal hyperthermia, but a full human model incorporating patient variables, heat delivery, and the impact of the circulatory system and anesthesia in HIPEC has not been established.
This project seeks to develop and validate a computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. It is hypothesized that by incorporating patient, anesthetic, and perfusion-related variables in a thermodynamic model, the temperatures inside and outside the abdomen during HIPEC can be predicted.
Detailed description
Peritoneal surface malignancies are a group of cancers arising from rare primary or common secondary tumors. Regardless of the etiology, the prognosis is poor and only a few therapies have shown promising results. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a well-established alternative for patients with these malignancies. Still, as many as 46% of patients recur early after treatment.
Although HIPEC has a predetermined protocol to manage body temperature, the resultant bladder and core-body temperatures are highly variable. Age, gender, body mass index, and type and duration of chemotherapy are key factors influencing the incidence and severity of bladder hyperthermia. While clinical and animal investigations have studied abdominal hyperthermia, a full human model incorporating patient variables, heat delivery, and the impact of the circulatory system and anesthesia in HIPEC has not been established.
To bridge this gap in knowledge, this project seeks to develop and validate a computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. It is hypothesized that by incorporating patient, anesthetic, and perfusion-related variables in a thermodynamic model, the temperatures inside and outside the abdomen during HIPEC can be predicted. By predicting temperature changes during HIPEC, clinicians can improve the safety and efficacy of therapeutic hyperthermia.
The hypothesis will be evaluated through two specific aims:
Specific aim 1: To develop a computational, thermodynamic model of intraabdominal hyperthermia for humans undergoing HIPEC. The rationale is that existing thermodynamic models are designed for non-anesthetized or hypothermic humans, implying the need of a new model with the conditions of a HIPEC treatment.
Specific aim 2: To validate our novel computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. Our rationale is that by using real-world data, the initial (SA1) computational model can be optimized and ultimately used to formulate individualized hyperthermia treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC | – | Other: Additional temperature monitoring/recordingAdults undergoing cytoreductive surgery and who are deemed eligible for HIPEC after surgical exploration in the operating theatre. The patients will receive HIPEC according to routine practice, as defined by the surgical oncologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of all patients who are scheduled to undergo hyperthermic intraperitoneal chemotherapy (HIPEC) for abdominal cancer at Henry Ford Main Hospital
Key inclusion criteria (2 listed)
- Adults (at least 18 years or older)
- Scheduled to undergo HIPEC surgery for abdominal cancer at HFH-Main
Key exclusion criteria (3 listed)
- Pregnant females
- Minors
- Disease not amenable for treatment with HIPEC after surgical examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional temperature monitoring/recordingAll patients in this study will receive the same standard of care treatment for their HIPEC procedure. The only difference will be the use of additional temperature probes to collect more robust data regarding intraabdominal temperature, and the prospective collection of actual boundary conditions of the system. | Other | HIPEC |
Primary outcome
Core-body Temperature (Celsius)
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment.
Bladder temperature (Celsius)
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment.
19 secondary outcomes
Mean Temperature of the Skin (C)
Time frame: Duration of HIPEC procedure (2-4 hours)
Intrabdominal wall tissue temperature (Celsius)
Time frame: Duration of HIPEC procedure (2-4 hours)
Set Temperature (Celsius)
Time frame: Duration of HIPEC procedure (2-4 hours)
Inflow Temperature (Celsius)
Time frame: Duration of HIPEC procedure (2-4 hrs)
Outflow Temperature (Celsius)
Time frame: Duration of HIPEC procedure (2-4 hours)
HIPEC Flow
Time frame: Duration of HIPEC procedure (2-4 hours)
Operating Room Temperature (Celsius)
Time frame: Duration of HIPEC procedure (2-4 hours)
Underbody Blanket Temperature (Celsius)
Time frame: Duration of HIPEC procedure (2-4 hours)
Convection Air Blanket Temperature (Celsius)
Time frame: Duration of HIPEC procedure (2-4 hours)
Intrabdominal Cavity Volume (mL)
Time frame: Preoperative, on average within 3 months prior to surgery.
Peritoneal Cavity Volume (mL)
Time frame: Preoperative, on average within 3 months prior to surgery.
Abdominal Volume (mL)
Time frame: Preoperative, on average within 3 months prior to surgery.
Blood Pressure (mmHg)
Time frame: Duration of HIPEC procedure (2-4 hours)
Heart Rate (beats/min)
Time frame: Duration of HIPEC procedure (2-4 hours)
Cardiac Output (L/min)
Time frame: Duration of HIPEC procedure (2-4 hours)
Stroke Volume Variation (%)
Time frame: Duration of HIPEC procedure (2-4 hours)
Body fat percentage (%)
Time frame: Preoperative, obtained the day of surgery.
Weight (Kg)
Time frame: Preoperative, obtained the day of surgery.
Height (m)
Time frame: Preoperative, obtained the day of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Background: PubMed 33487083Loke DR, Helderman RFCPA, Rodermond HM, Tanis PJ, Streekstra GJ, Franken NAP, Oei AL, Crezee J, Kok HP. Demonstration of treatment planning software for hyperthermic intraperitoneal chemotherapy in a rat model. Int J Hyperthermia. 2021;38(1):38-54. doi: 10.1080/02656736.2020.1852324.
- Background: PubMed 29564201Ladhari T, Szafnicki K. Modelling of some aspects of a biomedical process: application to the treatment of digestive cancer (HIPEC). 3 Biotech. 2018 Apr;8(4):190. doi: 10.1007/s13205-018-1211-5. Epub 2018 Mar 20.
- Background: PubMed 4807388Stolwijk JA, Nadel ER, Wenger CB, Roberts MF. Development and application of a mathematical model of human thermoregulation. Arch Sci Physiol (Paris). 1973;27(3):303-10. No abstract available.
- Background: PubMed 17762076Severens NM, van Marken Lichtenbelt WD, Frijns AJ, Van Steenhoven AA, de Mol BA, Sessler DI. A model to predict patient temperature during cardiac surgery. Phys Med Biol. 2007 Sep 7;52(17):5131-45. doi: 10.1088/0031-9155/52/17/002. Epub 2007 Aug 7.
- Individual participant dataSharing planned: No
Related trials for HIPEC
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Not yet recruitingPhase 2
Application of Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (Diagnosis)
Not yet recruitingObservational study
Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases
Hyperthermic Intraperitoneal Chemotherap, Colorectal Cancer Metastatic
Active, not recruitingPhase 1
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer
RecruitingPhase 2
HIPEC Priming Followed by Serplulimab Plus SOX/XELOX in Locally Advanced Gastric Cancer
Locally Advanced Gastric Cancer, Gastric Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Guerra, MD principal investigator
Staff Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIPEC, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Nowak, PhD (313-771-7128, knowak2@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core-body Temperature (Celsius) (time frame: Duration of HIPEC procedure (2-4 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426928, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.