Clinical trial NCT05203809: Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies
Official title: Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haematological Malignancy
Leukemia
Lymphoma
Myeloma
Temperature Change, Body
Keywords: temperature monitor
continuous
wireless
febrile neutropenia
Lead sponsor: Malaghan Institute of Medical Research
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This pilot study aims to recruit 15-20 participants undergoing treatment at Wellington Regional Hospital between November 2021 and June 2022. These will be patients with either acute leukaemia, lymphoma or myeloma that are requiring intensive treatment for their haematological malignancy, such as induction chemotherapy (e.g. doxorubicin/cytarabine for acute myeloid leukaemia), autologous stem cell transplantation, allogeneic stem cell transplantation or chimaeric antigen receptor (CAR) T-cell therapy. Their treatment may be delivered as an inpatient or outpatient (with outpatient treatment more likely in the setting of autologous stem cell transplantation or CAR T-cell therapy).

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.

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.

Primary outcomes:
measure: Time device was worn
timeFrame: 14 days
Secondary outcomes:
measure: Device usability based on System Usability Scale questionnaire
timeFrame: 12 days
measure: Participant interest in device, based on Intrinsic Motivation Index questionnaire
timeFrame: 12 days
measure: Participant preference for TempTraq or CORE device
timeFrame: 14 days
measure: Comparability to intermittent ear thermometer data
timeFrame: 14 days
measure: Time between fever identification
timeFrame: 14 days
measure: Rates of skin irritation or infection
timeFrame: 14 days
measure: Participant age in years
timeFrame: 14 days
measure: Participant ethnicity
timeFrame: 14 days
measure: Participant diagnosis
timeFrame: 14 days
measure: Participant body mass index
timeFrame: 14 days
measure: Haematological treatment that participant is undergoing during study period
timeFrame: 14 days
Other outcomes:
Locations:
city: Wellington
country: New Zealand
facility: Malaghan Institute of Medical Research
Study officials:
References: