Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC

HIPEC Clinical Trial

— HIPEC  

Official title:

Development of a Computational, Thermodynamic Model of Intraabdominal Hyperthermia in Humans Undergoing HIPEC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426928
• Other study ID #: 15538
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Henry Ford Health System
• Contact: Katherine Nowak, PhD
• Phone: 313-771-7128
• Email: knowak2[@]hfhs.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (at least 18 years or older)

• Scheduled to undergo HIPEC surgery for abdominal cancer at HFH-Main

Exclusion Criteria:

• Pregnant females

• Minors

• Disease not amenable for treatment with HIPEC after surgical examination.

Related Conditions & MeSH terms

• Fever
• HIPEC
• Hyperthermia

Intervention

Other:
• Additional temperature monitoring/recording
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.

Locations

Country	Name	City	State
United States	Katherine Nowak	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ladhari 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. — View Citation

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. — View Citation

Severens 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. — View Citation

Stolwijk 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core-body Temperature (Celsius)	Temperature values over time during a HIPEC treatment.	Duration of HIPEC procedure (2-4 hours)
Primary	Bladder temperature (Celsius)	Temperature values over time during a HIPEC treatment.	Duration of HIPEC procedure (2-4 hours)
Secondary	Mean Temperature of the Skin (C)	Weighed calculation of the skin temperature values over time during a HIPEC treatment.	Duration of HIPEC procedure (2-4 hours)
Secondary	Intrabdominal wall tissue temperature (Celsius)	Temperature values over time during a HIPEC treatment.	Duration of HIPEC procedure (2-4 hours)
Secondary	Set Temperature (Celsius)	Temperature values over time during a HIPEC treatment	Duration of HIPEC procedure (2-4 hours)
Secondary	Inflow Temperature (Celsius)	Temperature values over time during a HIPEC treatment	Duration of HIPEC procedure (2-4 hrs)
Secondary	Outflow Temperature (Celsius)	Temperature values over time during a HIPEC treatment	Duration of HIPEC procedure (2-4 hours)
Secondary	HIPEC Flow	Flow values (mL/min) over time during a HIPEC treatment	Duration of HIPEC procedure (2-4 hours)
Secondary	Operating Room Temperature (Celsius)	Temperature values over time during a HIPEC treatment	Duration of HIPEC procedure (2-4 hours)
Secondary	Underbody Blanket Temperature (Celsius)	Temperature values over time during a HIPEC treatment	Duration of HIPEC procedure (2-4 hours)
Secondary	Convection Air Blanket Temperature (Celsius)	Temperature values over time during a HIPEC treatment	Duration of HIPEC procedure (2-4 hours)
Secondary	Intrabdominal Cavity Volume (mL)	3D-lab post-processing of preoperative CT scans.	Preoperative, on average within 3 months prior to surgery.
Secondary	Peritoneal Cavity Volume (mL)	3D-lab post-processing of preoperative CT scans.	Preoperative, on average within 3 months prior to surgery.
Secondary	Abdominal Volume (mL)	3D-lab post-processing of preoperative CT scans.	Preoperative, on average within 3 months prior to surgery.
Secondary	Blood Pressure (mmHg)	Blood pressure values over time during a HIPEC treatment.	Duration of HIPEC procedure (2-4 hours)
Secondary	Heart Rate (beats/min)	Heart rate values over time during a HIPEC treatment.	Duration of HIPEC procedure (2-4 hours)
Secondary	Cardiac Output (L/min)	Cardiac output values over time during a HIPEC treatment.	Duration of HIPEC procedure (2-4 hours)
Secondary	Stroke Volume Variation (%)	Stroke volume variation values over time during a HIPEC treatment.	Duration of HIPEC procedure (2-4 hours)
Secondary	Body fat percentage (%)	Determined by impedancemetry	Preoperative, obtained the day of surgery.
Secondary	Weight (Kg)	Participant's weight	Preoperative, obtained the day of surgery.
Secondary	Height (m)	Participant's height	Preoperative, obtained the day of surgery.