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

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.

Conditions

• Cytokine Release Syndrome
• Neoplasms
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Multiple Myeloma
• Lymphoma Mantle-cell
• Immunotherapy
• Cell and Tissue-Based Therapy
• Cytokines
• Monitoring Physiologic
• Immune Monitoring
• Wearable Electronic Devices
• Thermometry
• Body Temperature
• Antibodies Bispecific
• Receptors Chimeric Antigen

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)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Nicholas P Tschernia, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-27

Primary Completion

2029-06-30

Completion

2029-08-18

Countries

• United States

Study Locations