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A Randomized Controlled Trial of a Wearable Core Body Temperature Sensor Versus Standard Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Patients Undergoing CAR T-Cell Therapy in an Outpatient Setting
Sponsor: Wake Forest University Health Sciences
Summary
The purpose of this research study is to see if a wearable temperature monitoring patch can detect cytokine release syndrome earlier than traditional oral temperature monitoring.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2026-12
Completion Date
2029-01-02
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
TempShield Continuous Temperature Monitoring
Patient participants will receive instruction from a research designee regarding use of the TempShield patch and smartphone application for continuous at-home temperature monitoring. Patient participants will complete onboarding of the application on their smartphone with assistance from the research designee, if necessary. Patient participants should place the patch immediately after completion of CAR-T infusion in the outpatient setting, with assistance from the research designee.
Standard of Care
Standard of care oral temperature monitoring
Locations (2)
Atrium Health Levine Cancer
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States