Fever Support in Pediatric Oncology (FeSuPO): A pilot study protocol for a multi-center randomized controlled tria

Fever Support in Pediatric Oncology (FeSuPO): A pilot study protocol for a multi-center randomized controlled tria - FeSuPO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028273

Enrollment

Registered

2022-04-14

Start date

2022-10-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever

Interventions

Group 1: Experimental intervention: Gentle but active warming support with onset of inpatient admission for fever. On the ward, patients are gently warmed with electric warming blankets or hot water b

Eligibility

Sex/Gender

All

Age

1 Years to 17 Years

Inclusion criteria

Inclusion criteria: Essential inclusion criteria: Presence of oncologic disease; Initiation of chemotherapy; Need for hospitalization due to a core body temperature = 38.5 °C within 3 months of chemotherapy initiation; Patients between the ages of 1 and 17 years; Informed consent from legal guardians and patient 14 years of age or older

Exclusion criteria

Exclusion criteria: Major exclusion criteria: Evidence of acute brain injury by computed tomography; Malignant hyperthermia (ever occurred); Neuroleptic malignant syndrome (ever occurred); Hepatic cirrhosis (ever occurred); Acute hepatic failure; History of stroke, seizure, or traumatic brain injury

Design outcomes

Primary

Measure	Time frame
Objective of this pilot study (Eldridge et al., 2016) is a.) proof of principle and definition of intervention, b.) review and optimize operationalization of the intervention, c.) evaluation of safety and feasibility of study design, d.) including identification of contraindications to the intervention and termination criteria, e.) definition of primary and secondary outcomes for main study, f.) determination of required sample size and recruitment time, g.) determination of relevant covariates beside study side, h.) determination of resource and cost requirements for the intended multicenter study.	—

Measure

Time frame

Objective of this pilot study (Eldridge et al., 2016) is a.) proof of principle and definition of intervention, b.) review and optimize operationalization of the intervention, c.) evaluation of safety and feasibility of study design, d.) including identification of contraindications to the intervention and termination criteria, e.) definition of primary and secondary outcomes for main study, f.) determination of required sample size and recruitment time, g.) determination of relevant covariates beside study side, h.) determination of resource and cost requirements for the intended multicenter study.

—

Secondary

Measure	Time frame
This includes generating experience regarding the goal and implementation (e.g., achieving and maintaining a difference between central and peripheral body temperature of <0.2 °C within 3 hours, and/or standardizing and measuring room temperature in terms of hot water bottles, heat packs, electric blankets, warm drinks, etc.) of equalizing central and peripheral body temperature as quickly as possible.	—

Measure

Time frame

This includes generating experience regarding the goal and implementation (e.g., achieving and maintaining a difference between central and peripheral body temperature of <0.2 °C within 3 hours, and/or standardizing and measuring room temperature in terms of hot water bottles, heat packs, electric blankets, warm drinks, etc.) of equalizing central and peripheral body temperature as quickly as possible.

—

Countries

Germany

Contacts

Public ContactDavid Martin

Universität Witten/Herdecke, Fakultät für Gesundheit (Department für Humanmedizin)

david.martin@uni-wh.de+49 (0)2330 / 62-3810

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026