Continuous Temperature Monitoring for Cytokine Release Syndrome

KC
NP
Overseen ByNicholas P Tschernia, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: National Cancer Institute (NCI)
Must be taking: Immunotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a small patch called TempTraq can detect fever early to prevent severe cytokine release syndrome (CRS), a condition that may occur after cancer treatment. CRS can cause symptoms such as fever and breathing problems. Participants will wear the patch to continuously monitor their temperature while staying at the NIH clinic. This trial targets adults with cancer receiving specific treatments at the clinic. The goal is to determine if monitoring body temperature can help catch signs of CRS early, potentially preventing serious complications. As an unphased trial, this study allows patients to contribute to innovative research that could enhance the safety of cancer treatments.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on antibiotics for an active infection, you cannot participate in the trial.

What prior data suggests that continuous temperature monitoring is safe for cancer patients?

Research has shown that using devices like TempTraq for continuous temperature monitoring is generally safe for patients. This method closely tracks body temperature, enabling early detection of potential issues such as cytokine release syndrome (CRS). CRS can occur after cancer treatments and cause symptoms like fever and low blood pressure. Studies indicate that continuous monitoring complements regular checks by adding an extra layer of safety through real-time information.

The TempTraq patch used in this trial is approved for fever monitoring, suggesting it is well-tolerated with minimal risks. Research has not reported significant negative effects from its use, making it a promising tool for those undergoing treatments that might lead to CRS. Continuous monitoring aims to enhance patient safety by identifying problems early and reducing the risk of severe side effects.12345

Why are researchers excited about this trial?

Researchers are excited about continuous temperature monitoring (CTM) for cytokine release syndrome because it offers a proactive way to manage this serious condition. Unlike traditional methods that react to symptoms after they appear, CTM allows for real-time tracking of temperature changes with devices like TempTraq, which can provide actionable alerts. This means healthcare providers can intervene earlier, potentially preventing severe reactions. Additionally, the option to use black-boxed VitalTraq devices adds another layer of monitoring, which may improve patient outcomes by offering more comprehensive data.

What evidence suggests that continuous temperature monitoring is effective for detecting cytokine release syndrome?

This trial will compare different approaches to continuous temperature monitoring for detecting cytokine release syndrome (CRS). Studies have shown that constant body temperature tracking can help identify fevers earlier in patients at risk of developing CRS, a serious potential side effect of cancer treatments that can cause symptoms like fever and low blood pressure. Participants in the intervention arm will use TempTraq with actionable alerts, which research indicates can detect fevers before they become severe. In studies with similar devices, early fever detection was linked to better management of CRS. This suggests that continuous monitoring could improve patient outcomes by providing timely alerts.12678

Who Is on the Research Team?

NP

Nicholas P Tschernia, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for adults (18+) with cancer who are staying at the NIH clinic and receiving certain immune-based treatments that can cause serious cytokine release syndrome. Participants must be able to understand and agree to join the study.

Inclusion Criteria

I am 18 years old or older.
I am in an NIH trial using new immune therapies with a risk of severe side effects.
I am receiving immunotherapy and am admitted to the Clinical Center.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TempTraq patches and a special NIH tablet for continuous temperature monitoring during their hospital stay

Up to 15 days
Continuous monitoring during hospital stay

Follow-up

Participants are monitored for CRS symptoms and other vital signs for a total of 2 months from enrollment

2 months

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Temperature Monitoring (CTM)

Trial Overview

The study tests if a wearable patch called TempTraq, which continuously monitors body temperature, can help detect fever early in people at risk for cytokine release syndrome during cancer treatment. Some may also use VitalTraq on a tablet to check vital signs daily.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Arm 1Experimental Treatment2 Interventions
Group II: Control Arm 2Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

Continuous Temperature Monitoring (CTM) for Cytokine ...

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 ...

Continuous Temperature Monitoring (CTM) for Cytokine ...

Cytokines are proteins that play a role in the immune system. CRS can cause fever, chills, fatigue, low blood pressure, or breathing problems.

Continuous temperature monitoring for the detection of fever ...

This pilot study explored the acceptability and feasibility of two continuous temperature monitoring devices, CORE® and TempTraq®, in 15 inpatients at risk ...

a pilot study of two wearable devices ( THERMAL )

This pilot study explored the acceptability and feasibility of two continuous temperature monitoring devices, CORE® and TempTraq®, ...

Continuous Temperature Monitoring (CTM) for Cytokine Release ...

This study tests if a wearable temperature patch can help detect a serious side effect called Cytokine Release Syndrome (CRS) earlier. It is for cancer patients ...

Digital Biomarkers of Cytokine Release Syndrome - PMC

Continuous monitoring of temperature, SpO2, and heart rate with DHTs greatly enhances the ability to track clinical status through objective ...

How AI-Driven Continuous Monitoring Can Improve ...

Remote monitoring solution for cytokine release syndrome paves the way for more consistent patient care, a deeper understanding of immune ...

Digital Remote Patient Monitoring for Cytokine Release ...

Results: The remote patient monitoring data will be analyzed to identify any significant changes in vital signs preceding the onset of CRS.