Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies

NCT ID: NCT05203809

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2022-06-30

Brief Summary

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.

Detailed Description

Patients with haematological malignancies such as leukaemia, lymphoma and myeloma often require intensive treatments such as chemotherapy, stem cell transplantation (either autologous or allogeneic) or CAR T-cell therapy. All these therapies can lead to a period of prolonged neutropenia, or low neutrophils, when they are at very high risk of serious bacterial infections. While other countries use routine prophylactic antibiotics, Australasian practice is to focus on prompt recognition and treatment of infections. There is clear evidence that early recognition and treatment of febrile neutropenia with antibiotics leads to improved outcomes, with each hour delay in antibiotic administration associated with an 18% increase in mortality.

Current practice is to detect fevers by both routine and symptom-based intermittent ear thermometer testing, with routine monitoring being approximately every four hours. However, neutropenic patients may not develop symptoms before manifesting a fever, meaning that continuous temperature monitoring could potentially lead to earlier recognition and treatment of febrile neutropenia.

This pilot study seeks to determine the feasibility of using two separate continuous skin temperature monitors during intensive treatment for haematological malignancies, in the inpatient and outpatient setting. If feasible, this could be used to increase the amount of treatments that can be safely performed as outpatients, as well as allowing earlier identification and treatment of febrile neutropenia.

The two proposed measuring devices are: 1. TempTraq adhesive temperature sensor, a skin temperature sensor which is applied to the axilla for 72 hours, then replaced; and 2. CORE temperature sensor, a rechargeable skin temperature sensor that is attached to the chest with a chest strap.

The TempTraq device is an FDA cleared class 2 medical device, while the CORE temperature monitor has received emergency FDA approval as a medical device in the context of the COVID-19 pandemic.

If these devices are demonstrated to be feasible, the technology could potentially be used to improve monitoring of immunosuppressed patients out of hospital, allowing patients to receive treatment out of hospital or closer to home. It may also allow earlier detection of febrile neutropenia, and reduce the mortality from this.

Conditions

Haematological Malignancy; Leukemia; Lymphoma; Myeloma; Temperature Change, Body

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation group

Group of participants wearing continuous temperature monitoring device

TempTraq temperature monitor

Intervention Type: DEVICE

All participants will wear both TempTraq temperature monitor and CORE temperature monitor.

Interventions

TempTraq temperature monitor

All participants will wear both TempTraq temperature monitor and CORE temperature monitor.

Intervention Type: DEVICE

Other Intervention Names

CORE temperature monitor

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Malaghan Institute of Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Malaghan Institute of Medical Research

Wellington, , New Zealand

Site Status: RECRUITING

Countries

New Zealand

Facility Contacts

Robert C Fyfe, MBChB

Role: primary

rfyfe@malaghan.org.nz

0064212066662

Robert Weinkove, MBBS, PhD

Role: backup

rweinkove@malaghan.org.nz

0064221746400

References

Fyfe 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 Sep 26. doi: 10.1111/imj.70199. Online ahead of print.

Reference Type: DERIVED

PMID: 41001994 (View on PubMed)

Other Identifiers

H21/161

Identifier Type: -

Identifier Source: org_study_id