Thermodynamic Model of Hyperthermia in Humans Undergoing HIPEC

Henry Ford Health

Status: Enrolling

Conditions: HIPEC

Treatments: Other: Additional temperature monitoring/recording

Study type: Observational

Funder types: Other

Identifiers

NCT05426928

15538

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

HIPEC

Description:

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.

Treatment:

Other: Additional temperature monitoring/recording