Clinical trial · Observational
Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies
Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)
NCT05203809CI-TRIAL-00056110THERMALunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The THERMAL study is a pilot study to determine feasibility of using two separate continuous skin temperature monitors during intensive treatment for haematological malignancies. It involves participants wearing both the TempTraq and CORE temperature devices for up to 14 days, and then assessing their feasibility and tolerability with quantitative, semiquantitative and qualitative methods.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Haematological Malignancy | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Temperature Change, Body | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TempTraq temperature monitor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observation group
- description
- Group of participants wearing continuous temperature monitoring device
- interventionNames
- Device: TempTraq temperature monitor
Primary outcomes (1)
- measure
- Time device was worn
- timeFrame
- 14 days
- description
- Percentage of time that both CORE and TempTraq were worn against total time available
Secondary outcomes (11)
- measure
- Device usability based on System Usability Scale questionnaire
- timeFrame
- 12 days
- description
- Comparison of results from System Usability Scale (SUS) questionnaire for both devices at day 4, 8 and 12. The SUS is reported on a scale of 1-5, with 5 indicating the best response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 16-75 years * Diagnosis of acute leukaemia, lymphoma or myeloma by consultant haematologist or multidisciplinary meeting discussion * Undergoing treatment with either induction chemotherapy, autologous stem cell transplant, allogeneic stem cell transplant, or chimeric antigen receptor (CAR) T-cell therapy as part of their normal care. Exclusion Criteria: * Medical condition that would result in discomfort from the application of chest or axillary monitoring. * Allergy to a component of the monitoring devices * Diminished capacity or any circumstance that would prohibit them from understanding and providing informed consent in accordance with ICH-GCP (International Conference on Harmonisation, Good Clinical Practice) principles.
References
Publications (1)
- DERIVEDFyfe RC, Larsen M, Blud D, Weinkove R. Continuous temperature monitoring for the detection of fever in haemato-oncology patients: a pilot study of two wearable devices (THERMAL). Intern Med J. 2025 Nov;55(11):1928-1933. doi: 10.1111/imj.70199. Epub 2025 Sep 26. PMID 41001994