Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event

Official Summary

Background: Drugs or cell therapies to treat cancer can sometimes cause cytokine release syndrome (CRS). That is, the body makes too many cytokines after treatment. Cytokines are proteins that play a role in the immune system. CRS can cause fever, chills, fatigue, low blood pressure, or breathing problems. Researchers want to know if continuously monitoring a person s body temperature can help reduce the chance of getting serious CRS. Objective: To learn if an approved patch called TempTraq can detect fever before serious CRS develops. Eligibility: People aged 18 years and older with cancer who are staying at the NIH clinic for treatment with drugs or cell therapies. Design: Participants will receive TempTraq patches and a special NIH tablet. The TempTraq is a small patch applied to clean, dry skin under the arm. It continually monitors body temperature and sends the data to an application on the tablet. Participants will wear the patch most of the time they are admitted to the hospital. They could wear it for up to 15 days. The patch monitoring does not replace regular temperature checks, all participants will still have have their regular temperature checks as part of their treatment plan. Participants may also opt to use VitalTraq, another application on the tablet. They will hold the screen up to their face for about 1 minute. VitalTraq uses the camera in the tablet to measure blood pressure, heart rate, and breathing. They will do this once per day while they are in the clinic; they may do it more often if they have a fever or feel unwell. Blood may be drawn for research. Participants will be asked about their experience within 1 week after TempTraq is removed. Participants who choose to use the patch, complete its use, and return at a later date for another treatment or study, may be able to re-enroll to have the patch used again.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 136 participants

Interventions

• DEVICE: TempTraq — Continuous temperature monitoring (CTM) wearable patch device
• DEVICE: VitalTraq — Multi-vital, multi-sensor smartphone/ tablet application allowing data collection of blood pressure, heart rate, heart rate variability, and respiration rate using Remote Photoplethysmography technology (rPPG)

Primary Outcomes

• To assess whether continuous observations of fevers with TempTraq versus intermittent fevers monitoring reduce the risk of progression to grade >= 3 cytokine release syndrome (CRS) (TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment)

Secondary Outcomes

• To assess whether continuous observations of fevers associated with CRS using TempTraq versus intermittent fevers monitoring reduce the duration of CRS episodes (TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment)
• To assess whether continuous observations of fevers associated with CRS using TempTraq versus intermittent fevers monitoring reduces the escalation of CRS care (TempTraq will be worn for up to 15 days inpatient, monitoring for CRS symptoms will continue for a total of 2 months from enrollment)

Trial Locations

• National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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