Alio Smart Patch Monitoring for Cancer Patients

Overseen By Alberto Montero, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: No cellphone access, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for tracking side effects in cancer treatment. Participants will wear a small device called the Alio Smart Patch™, which continuously monitors vital signs and blood levels. The goal is to detect potential side effects early for immediate treatment. This trial suits individuals with certain cancers, such as breast or pancreatic cancer, who are beginning a new chemotherapy regimen and face risks like infections. Participants must read or speak English and have cellphone access. As an unphased study, this trial provides a unique opportunity to contribute to innovative cancer care solutions.

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 seems focused on monitoring vital signs and blood levels, so you may not need to stop your medications, but it's best to confirm with the trial coordinators.

What prior data suggests that the Alio Smartpatch™ is safe for monitoring cancer patients?

Previous studies have used the Alio Smart Patch safely in various medical settings. This device is a non-invasive wearable sensor, meaning it doesn't require needles or surgery. It measures heart rate, skin temperature, and other important health signals. Patients undergoing dialysis have generally tolerated the Alio Smart Patch well.

The device detects early signs of health issues, such as side effects from chemotherapy, enabling doctors to respond more quickly. Research shows that people usually wear the patch as recommended, indicating it is comfortable and easy to use.

Overall, the Alio Smart Patch has not shown any major safety concerns in its use, suggesting it is a safe option for continuous health monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Alio Smart Patch™ because it offers a new way to monitor cancer patients continuously and remotely. Unlike traditional treatments that rely on periodic check-ups and subjective symptom reporting, this smart patch provides real-time physiological data, potentially detecting chemotherapy-related toxicities early. This approach could lead to more proactive management of side effects, improving patient safety and comfort during treatment.

What evidence suggests that the Alio Smart Patch™ is effective for monitoring cancer patients?

Research shows that the Alio Smart Patch™, used by participants in this trial, helps detect chemotherapy side effects early. Studies have found that this device continuously tracks vital signs and blood levels, allowing for earlier problem detection. Early detection enables treatment of side effects before they worsen. Continuous remote monitoring by clinical staff ensures quick response to any issues. This proactive approach aims to make cancer treatment safer by reducing risks. ^{1 2 3 6 7}

Who Is on the Research Team?

Alberto Montero, MD, MBA

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer patients at risk of febrile neutropenia, a condition with fever and low white blood cell count after chemotherapy. Participants should be willing to wear the Alio Smart Patch™ for continuous monitoring of vital signs and blood levels.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

I am expected to undergo chemotherapy for at least 12 weeks.

I am starting on immunotherapy alone or with chemotherapy for my treatment.

Exclusion Criteria

Participants without any cellphone access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy and are continuously monitored using the Alio Smart Patch for up to 13 weeks

13 weeks

Continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alio Smart Patch™

Trial Overview The study tests if using the Alio Smart Patch™ can help detect and treat side effects from chemotherapy earlier by continuously monitoring vital signs and blood levels, including glucose, with remote supervision by Quantify Remote Care.

How Is the Trial Designed?

Group I: Remote Monitoring with Smartpatch Experimental Treatment 1 Intervention

Participants will be continuously monitored through the device, providing crucial physiological data. The Smartpatch will allow for early detection of chemotherapy-related toxicities.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

The self-assessment smartphone app alerted 72.6% of users about concerning symptoms related to tobacco-induced diseases, with current smokers showing a higher incidence of symptoms like fatigue and cough, indicating a significant awareness of health issues.

During the study, the incidence of early-stage lung cancer (stages 1 and 2) increased to 24% among users, compared to 9% in the previous year, suggesting that the app may enhance early detection of lung cancer and encourage smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. Stavaux, E., Goupil, F., Barreau, G., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06657183

ECM and Monitoring w/ Alio Smart Patch in Cancer Pts ... The Smartpatch will allow for early detection of chemotherapy-related toxicities. Intervention/Treatment, Device : Alio Smart Patch™. Alio Smart Patch is a ...

2. withpower.com withpower.com/trial/phase-febrile-neutropenia-11-2024-fddd1

Alio Smart Patch Monitoring for Cancer Patients Trial Overview The study tests if using the Alio Smart Patch™ can help detect and treat side effects from chemotherapy earlier by continuously monitoring vital ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/550841

Alio Smart Patch in Cancer Pts Receiving Chemotherapy The Smartpatch will allow for early detection of chemotherapy-related toxicities. Device. Alio Smart Patch™. Alio Smart Patch is a non-invasive wearable ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-03944

Continuous Monitoring of Vital Signs and Laboratory ... The patient wears the Alio Smartpatch and the device measures vital signs and basic lab values. The data collected from the device is remotely monitored at all ...

5. reporter.nih.gov reporter.nih.gov/search/SEdZC1BRdUunxo60Mp3JZw/project-details/11054164

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223073.pdf

March 17, 2023 Alio, Inc. Kevin Go, MBA, RAC, CQA ... The SmartPatch sensor is indicated to provide measurement of heart rate, skin temperature, Hgb, Hct and a qualitative risk assessment of the ...

7. aakp.org aakp.org/aakp-innovator-series-alio-remote-monitoring-platform/

AAKP Innovator Series: Alio Remote Monitoring Platform Alio created a non-invasive remote monitoring platform for complications in dialysis patients, providing actionable insights to clinical care teams.