TempTraq + VitalTraq for Blood Cancers

Overseen By Chenyu Lin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Car-T, BiTE

Must not be taking: Epcoritamab

Disqualifiers: Non-FDA approved CAR-T, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new devices, TempTraq and VitalTraq, to monitor vital signs in people with blood cancers undergoing specific therapies. TempTraq is a skin patch that tracks body temperature, while VitalTraq is an app that uses a quick facial scan to estimate heart rate, blood pressure, and breathing rate. The goal is to detect potential treatment side effects, such as fever or inflammation, sooner. People with blood cancers who are receiving certain advanced treatments and own a compatible smartphone might be suitable for this trial. As an unphased trial, participants contribute to innovative research that may enhance monitoring and safety for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring vital signs in patients undergoing specific cancer therapies.

What prior data suggests that these vital sign monitoring devices are safe for patients with blood cancers?

Research has shown that TempTraq, a wearable device for monitoring temperature, is safe and comfortable for use by people, including children and those with weaker immune systems. The FDA has approved it, confirming it meets safety standards. Studies have found it can accurately track body temperature without causing discomfort or harm.

VitalTraq, in contrast, uses a smartphone app to measure vital signs with a quick facial scan. Although there is less direct research on its safety, its non-invasive nature suggests it is likely comfortable for users. Both devices aim to make health monitoring easier and safer for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TempTraq and VitalTraq treatments because they offer a novel approach to monitoring patients with blood cancers. Unlike traditional methods, which often involve intermittent manual checks, TempTraq provides continuous, real-time temperature monitoring through a wearable patch. This could lead to faster detection of fevers and infections, which is critical for patients undergoing treatments like CAR-T or BiTE. VitalTraq complements this by continuously tracking vital signs, potentially identifying complications earlier than standard care. Together, these technologies aim to enhance patient safety and treatment outcomes by providing more comprehensive and timely data.

What evidence suggests that these monitoring devices are effective for patients with blood cancers?

In this trial, participants will use TempTraq, a wearable patch that research has shown helps detect fevers by constantly monitoring body temperature. This is particularly beneficial for patients undergoing treatments such as stem cell transplants. TempTraq detects fevers faster and more reliably than traditional methods, enabling quicker medical responses.

Participants will also use VitalTraq, which utilizes a smartphone app to monitor vital signs like heart rate and blood pressure through a quick facial scan. This technology can help identify treatment-related issues earlier. Together, these tools could enhance patient care by detecting problems sooner in those receiving advanced therapies like CAR-T or BiTE. ^{2 3 4 6 7}

Who Is on the Research Team?

Chenyu Lin, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for pediatric patients with blood cancers undergoing CAR-T or BiTE therapies. Participants must be receiving one of several specific treatments, such as Blinatumomab or Tisagenlecleucel. The study excludes certain individuals based on criteria not specified here.

Inclusion Criteria

Willing and able to provide informed consent to the study

Able to read and understand English

Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening

Exclusion Criteria

I am currently being treated with Epcoritamab.

I am receiving a CAR-T or BiTE therapy that is not approved by the FDA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAR-T or BiTE therapy and are monitored using TempTraq and VitalTraq devices

2 weeks

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a survey on device burden

4 weeks

1 visit (in-person), survey at Day 28

What Are the Treatments Tested in This Trial?

Interventions

• TempTraq
• VitalTraq

Trial Overview The study tests TempTraq and VitalTraq devices in early detection of CRS, a potential side effect of cancer therapy. TempTraq monitors body temperature via a skin patch, while VitalTraq estimates BP, HR, HRV, and respiratory rate through a smartphone app.

How Is the Trial Designed?

Group I: Patients with hematologic malignancies Experimental Treatment 2 Interventions

Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Blue Spark Technologies

Collaborator

Trials

2

Recruited

80+

Published Research Related to This Trial

A case series involving three neutropenic pediatric cancer patients showed that a high-frequency temperature monitoring wearable device (WD) detected fevers earlier than traditional thermometers, identifying fevers 5 and 12 hours before thermometer readings.

The early detection of fever by the WD led to quicker medical evaluations and prompt antibiotic treatment, suggesting that home-based HFTM could improve infection-related outcomes in pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency temperature monitoring at home using a wearable device: A case series of early fever detection and antibiotic administration for febrile neutropenia with bacteremia. Nessle, CN., Flora, C., Sandford, E., et al.[2023]

The TempTraq® smart wearable thermometer showed a strong correlation with traditional tympanic temperature measurements, indicating it is a reliable method for monitoring children's temperatures.

Caregivers reported high satisfaction with the TempTraq® device, with all satisfaction scores exceeding 4 points, suggesting it is a convenient and effective tool for parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axillary temperature measurements based on smart wearable thermometers in South Korean children: comparison with tympanic temperature measurements. Choi, Y., Ahn, HY.[2022]

The whole body hyperthermia (WBH) treatment system at Haukeland University Hospital has demonstrated high accuracy in temperature monitoring, achieving a precision of +/- 0.01 degrees C, which is crucial for minimizing side effects during treatment.

The system is user-friendly, comfortable for patients, and cost-effective, utilizing standard medical thermistor probes and a calibration facility to ensure reliable temperature control during WBH procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A thermometry system for quality assurance and documentation of whole body hyperthermia procedures. Hjertaker, BT., Frøystein, T., Schem, BC.[2006]

Continuous temperature monitoring using the TempTraq patch in a pilot study of 10 pediatric patients showed improved fever detection compared to standard episodic monitoring, identifying fevers that were missed or delayed by over 12 hours.

Caregivers found the TempTraq patch to be tolerable and easy to apply, suggesting it could be a practical tool for monitoring fever in immunocompromised patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of continuous temperature monitoring in pediatric immunocompromised patients: A pilot study. Sampson, M., Hickey, V., Huber, J., et al.[2019]

A novel wrist-worn sensor for continuously measuring core body temperature (CBT) showed a good correlation with reference measurements from ingestible temperature-sensing pills, with a correlation coefficient of r = 0.72.

The wrist-worn device demonstrated a small average bias of 0.11 °C compared to reference CBT, indicating it could be a reliable option for remote monitoring of body temperature, especially in the context of the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free-living core body temperature monitoring using a wrist-worn sensor after COVID-19 booster vaccination: a pilot study. Etienne, S., Oliveras, R., Schiboni, G., et al.[2023]

The Verily Patch, a novel wearable temperature monitor, accurately measures body temperature with a small error margin of 0.35 ± 0.88°F compared to traditional oral temperature assessments in high-risk patients after chemotherapy.

The device demonstrated high sensitivity (90.2%) and specificity (87.8%) in detecting fever episodes, significantly outperforming traditional methods by detecting 14.3 times more fever episodes with an average lead time of 4.3 hours, suggesting it could improve clinical outcomes for patients at risk of febrile neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Wearable Device for Continuous Temperature Monitoring & Fever Detection. Verma, N., Haji-Abolhassani, I., Ganesh, S., et al.[2021]

The study utilized miniaturized, battery-free wireless chips implanted in tumors of small animals to monitor temperature changes, revealing distinct temperature patterns associated with different cancer treatments, such as T cell transfer and chemotherapy.

Tracking tumor and body temperature dynamics can provide early insights into treatment responses, potentially improving cancer management without the need for complex imaging or lab tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor therapeutic response monitored by telemetric temperature sensing, a preclinical study on immunotherapy and chemotherapy. Shao, Q., Lundgren, M., Lynch, J., et al.[2023]

Citations

1. uhhospitals.org uhhospitals.org/for-clinicians/articles-and-news/articles/2017/06/clinical-study-shows-temptraq-wearable-bluetooth-continuous-temperature-monitor

Clinical Study Shows TempTraq® Wearable, Bluetooth® ... “This temperature monitoring patch has the potential to improve clinical outcomes for patients undergoing stem cell transplant and intensive ...

2. temptraq.healthcare temptraq.healthcare/hospital-successfully-tests/

Pediatric Cancer Patients TempTraq wearable, Bluetooth patch measures temperature continuously, detecting fevers faster and more consistently than episodic body temperature monitoring.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pbc.29835

High‐frequency temperature monitoring at home using a ... TempTraqR WD data are automatically uploaded via Bluetooth connection through a smartphone application and stored on a HIPAA secured web ...

4. temptraq.healthcare temptraq.healthcare/clinical-studies/

Clinical Studies This study compared temperature measurements taken with TempTraq to traditional tympanic measurements in 41 pediatric patients.

5. temptraq.healthcare temptraq.healthcare/carevive-bluespark-remote-patient-monitoring-pilot/

New Remote Patient Monitoring Pilot Patients in the study will report their symptoms through Carevive's PROmpt® while wearing Blue Spark's TempTraq®, a soft wearable patch that ...

6. temptraq.healthcare temptraq.healthcare/

TempTraq: Home TempTraq is an FDA Cleared Class II medical device that gives Healthcare providers the first wireless continuous temperature monitor.

7. withpower.com withpower.com/trial/phase-hematologic-neoplasms-9-2024-4fe85

TempTraq + VitalTraq for Blood Cancers · Info for Participants The TempTraq wearable temperature monitor has been studied for safety and tolerability in humans, including children and immunocompromised patients. It was ...