Haematological MalignancyTHERMALNCT05203809
Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies
An observational study of Haematological Malignancy and Leukemia, run by Malaghan Institute of Medical Research at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Haematological Malignancy, Leukemia, Lymphoma
- What is being tested?
- TempTraq temperature monitor
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 18 Nov 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
Malaghan Institute of Medical Research
Wellington, 6012
Robert C Fyfe, MBChB, 0064212066662, rfyfe@malaghan.org.nz
Robert Weinkove, MBBS, PhD, 0064221746400, rweinkove@malaghan.org.nz
About this study
Official title: Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)
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.
Read the 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
- Being tested
- TempTraq temperature monitor
- Keywords
- temperature monitor, continuous, wireless, febrile neutropenia
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Neoplasms, Plasma Cell, Body Temperature Changes, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TempTraq temperature monitorDevice
Also called CORE temperature monitor
All participants will wear both TempTraq temperature monitor and CORE temperature monitor.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Group of participants wearing continuous temperature monitoring device Receives: Device: TempTraq temperature monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time device was worn
Percentage of time that both CORE and TempTraq were worn against total time available
Measured: 14 days
Secondary outcomes (11)
Device usability based on System Usability Scale questionnaire
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.
Measured: 12 days
Participant interest in device, based on Intrinsic Motivation Index questionnaire
Comparison of results from Intrinsic Motivation Index questionnaires for both devices at day 4, 8 and 12. The IMI is reported on a 1-6 scale, with 6 in general indicating a better outcome (however several questions require the result to be reversed).
Measured: 12 days
Participant preference for TempTraq or CORE device
Whether participant had a preference for once device over the other at completion of monitoring. This is to be indicated with a binary "TempTraq or CORE" question.
Measured: 14 days
Comparability to intermittent ear thermometer data
Whether the TempTraq and CORE recordings correlated to intermittent ear thermometer recordings at the same timepoints (intermittent ear thermometers being the current standard of care).
Measured: 14 days
Time between fever identification
Difference in time between fever identification via TempTraq and CORE temperature devices and intermittent ear thermometer
Measured: 14 days
Rates of skin irritation or infection
Percentage of devices noted to have skin irritation or infection.
Measured: 14 days
Participant age in years
Age in years, to be reported with median and range, to allow description of participant characteristics
Measured: 14 days
Participant ethnicity
Participant self-identification of ethnicity, as per New Zealand Ministry of Health Ethnicity Data Protocols, Level 1 numbering hierarchy (as described in: https://www.health.govt.nz/publication/hiso-100012017-ethnicity-data-protocols)
Measured: 14 days
Participant diagnosis
Histological classification of diagnosis, as per World Health Organisation classification of haematological malignancies.
Measured: 14 days
Participant body mass index
Body mass index at enrolment in kg/m2, using height and weight.
Measured: 14 days
Haematological treatment that participant is undergoing during study period
Haematological treatment, such as chemotherapy, cellular therapy e.g. CAR T-cell therapy, or stem cell therapy (whether allogeneic or autologous).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start18 Nov 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haematological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malaghan Institute of Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203809
- Sponsor's protocol ID
- H21/161
- Acronym
- THERMAL
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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 Nov;55(11):1928-1933. doi: 10.1111/imj.70199. Epub 2025 Sep 26.
PubMed 41001994
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)
- ClinicalTrials.gov ID
- NCT05203809
- Acronym / sponsor ID
- THERMAL / H21/161
- Conditions
- Haematological Malignancy, Leukemia, Lymphoma, Myeloma, Temperature Change, Body
- Keywords
- temperature monitor, continuous, wireless, febrile neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Malaghan Institute of Medical ResearchUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Device: TempTraq temperature monitorGroup of participants wearing continuous temperature monitoring device |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TempTraq temperature monitorAlso: CORE temperature monitorAll participants will wear both TempTraq temperature monitor and CORE temperature monitor. | Device | Observation group |
Primary outcome
Time device was worn
Time frame: 14 days
Percentage of time that both CORE and TempTraq were worn against total time available
11 secondary outcomes
Device usability based on System Usability Scale questionnaire
Time frame: 12 days
Participant interest in device, based on Intrinsic Motivation Index questionnaire
Time frame: 12 days
Participant preference for TempTraq or CORE device
Time frame: 14 days
Comparability to intermittent ear thermometer data
Time frame: 14 days
Time between fever identification
Time frame: 14 days
Rates of skin irritation or infection
Time frame: 14 days
Participant age in years
Time frame: 14 days
Participant ethnicity
Time frame: 14 days
Participant diagnosis
Time frame: 14 days
Participant body mass index
Time frame: 14 days
Haematological treatment that participant is undergoing during study period
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 41001994Fyfe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haematological Malignancy and Leukemia, run by Malaghan Institute of Medical Research at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time device was worn (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05203809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.