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

32 Participants Needed

Trial Summary

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 data supports the effectiveness of the TempTraq + VitalTraq treatment for blood cancers?

Continuous temperature monitoring with devices like TempTraq has been shown to detect fevers earlier than standard methods, which is crucial for timely intervention in high-risk patients, such as those with blood cancers. Additionally, monitoring temperature changes can help assess the response to cancer treatments, as seen in studies where temperature patterns were linked to positive therapeutic responses in other cancer types. ^{1 2 3 4 5}

Is the TempTraq wearable temperature monitor safe for use in humans?

The TempTraq wearable temperature monitor has been studied for safety and tolerability in humans, including children and immunocompromised patients. It was found to be safe, easy to apply, and well-tolerated, with no significant safety concerns reported in the studies. ^{2 4 5 6 7}

How does the TempTraq + VitalTraq treatment for blood cancers differ from other treatments?

The TempTraq + VitalTraq treatment is unique because it involves continuous temperature monitoring using a smart wearable device, which allows for early detection of fever and better tracking of treatment response in blood cancer patients. This approach is different from traditional episodic temperature checks and can lead to more timely interventions and improved patient outcomes. ^{1 2 4 5 6}

What is the purpose of this trial?

The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.

Research Team

Chenyu Lin, MD

Principal Investigator

Duke University

Eligibility Criteria

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

Able to read and understand English

Willing and able to provide informed consent to the study

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Tumor therapeutic response monitored by telemetric temperature sensing, a preclinical study on immunotherapy and chemotherapy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of continuous temperature monitoring in pediatric immunocompromised patients: A pilot study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A thermometry system for quality assurance and documentation of whole body hyperthermia procedures. [2006]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

A Novel Wearable Device for Continuous Temperature Monitoring & Fever Detection. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Free-living core body temperature monitoring using a wrist-worn sensor after COVID-19 booster vaccination: a pilot study. [2023]

7. United States 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. [2023]