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Warming up for a better fever: a randomized pilot study in pediatric oncology
Hanno S Krafft1, Christa K Raak2, Ekkehart Jenetzky2,3
1Faculty of Health/School of Medicine, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448, Witten, Germany. hanno.krafft@uni-wh.de.
Insights
This pilot study explores gentle heat application for febrile pediatric oncology patients, aiming to reduce antipyretic use and improve fever management. Findings will inform larger trials on heat therapy
Area of Science:
- Pediatric Oncology
- Clinical Research
- Thermoregulation
Background:
- Fever management in pediatric oncology is challenging, often involving immediate antibiotic and antipyretic therapy.
- Antipyretics are not solely for temperature reduction; fever may enhance host defense and inhibit viral replication.
- Gentle heat application at fever onset could support the body's thermoregulatory set point.
Purpose of the Study:
- To evaluate the safety and feasibility of gentle heat application in febrile pediatric oncology patients.
- To gather data for sample size calculation and resource planning for a future multicenter trial.
- To assess the potential of heat application as an alternative to standard antipyretic treatment.
Main Methods:
- A 6-month randomized pilot study in a German academic hospital involving 24 pediatric oncology patients (18 months-17 years) with temperatures ≥ 38.0 °C.
- Intervention group: Gentle heat application with hot water bottles at fever onset, aiming for peripheral-trunk temperature equilibrium (< 0.5 °C), with avoidance of antipyretics.
- Control group: Standard antipyretic treatment as per hospital protocol.
Main Results:
- Pilot study data collection is ongoing.
- Focus on proof of principle, safety, feasibility, and endpoint definition.
- Preliminary data for sample size and resource estimation is being gathered.
Conclusions:
- The study aims to improve febrile episode care in pediatric cancer patients.
- Successful heat application could reduce discomfort, antipyretic, and potentially antibiotic use.
- This pilot study will provide a foundation for a main, multicenter randomized trial on heat application in pediatric oncology.
Background:
Fever in children is a major problem in pediatric oncology. Usual management leads to immediate antibiotic and antipyretic therapy, although there is consensus that antipyretic therapy should not be utilized with the sole aim of reducing body temperature. Increased body temperature during fever appears to be an effective modifier in terms of viral replication and enhanced host defense mechanisms against pathogens. Therefore, it might be beneficial to support febrile patients by applying gentle heat during the onset of fever to help the body to reach its new thermoregulatory set point.
Methods:
A randomized pilot study over 6 months will be conducted in a pediatric oncology department in an academic hospital in Germany. This study is a preparation for a multicenter clinical trial with two parallel groups concerning the efficacy of heat application vs. treatment as usual. One of the inclusion criteria is body temperatures ≥ 38.0 °C in n = 24 cases of patients receiving chemotherapy aged 18 months to 17 years. The first intervention consists of gentle heat application with hot water bottles at any sign of illness and onset of fever. The aim is to achieve a warm periphery equilibrated to trunk temperature of less than 0.5 °C. The second intervention is the avoidance of antipyretics. The control group receives the standard antipyretic treatment from the participating hospital. The purposes of this pilot study are proof of principle of intervention, evaluation of safety, feasibility, definition of endpoints, and to receive basic data for sample size calculation and needed resources.
Discussion:
The main goal is to improve the care of children with cancer by providing the best possible support for febrile episodes. If fever support by heat reduces discomfort, administration of antipyretics and maybe even antibiotics, this would be an advancement in oncological fever management. This pilot study is intended to provide a basis for a main, multicenter, randomized trial and demonstrate the practicability of heat application in febrile patients in pediatric oncology.
Trial Registration:
German Clinical Trials Register (DRKS), DRKS00028273 . Registered on 14 April 2022.
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