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Smart patch could spot chemo side effects before they become dangerous

NCT ID NCT06657183

Symptom relief Sponsor: Case Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This trial tests whether a wearable sensor called the Alio Smart Patch can help catch early signs of febrile neutropenia, a serious infection risk from chemotherapy. Thirty adults with certain cancers will wear the patch and a glucose monitor at home, with a remote care team watching their data 24/7. The goal is to see if this constant monitoring can spot problems sooner and improve patient safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Alio Smart Patch wearable sensor
What this could lead to
If successful, this could help doctors detect and treat dangerous side effects from cancer treatment earlier, potentially reducing hospital visits.
What could go wrong
This is a very small, early-stage study with only 30 participants, so results may not apply to all patients. The patch may be uncomfortable or unreliable for some.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

35 people

The number who actually took part.

Started

Aug 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: * Subjects have a diagnosis of soft tissue sarcoma, NSCLC, HNSCC, breast, pancreatic cancer, or melanoma * For Cohort 1 (n=15), participants are eligible if starting on a new chemotherapy regimen with either: (i) high risk (\> 20%) of febrile neutropenia as per NCCN MGF guidelines; or (ii) intermediate risk for febrile neutropenia AND one or more risk factors for febrile neutropenia: * Age \> or equal to 65 years * Advanced disease * Previous Chemotherapy or Radiation therapy * Preexisting neutropenia or bone marrow involvement with tumor * Infection * Open wounds or surgery in last 4 weeks * Poor performance status or poor nutritional status * Poor renal function (cr clearance \<50) * Total Bilirubin \>1.5 upper limit of normal * Cardiovascular Disease * Multiple Co-morbidities * HIV infection * BMI \> 2.0 * For Cohort 2 (n=15) participants are eligible if starting on immunotherapy alone, or concurrent chemo-immunotherapy. * Participants are capable of giving informed consent * Participants must be able to read and/or to speak English * Participants who are 18 years of age or older * Expected chemotherapy treatment duration of at least 12 weeks Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: * Participants who cannot read or speak English * Participants without any cellphone access

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Conditions

The condition(s) this trial relates to.

breast cancer Febrile Neutropenia head and neck squamous cell carcinoma malignant pancreatic neoplasm melanoma non-small cell lung carcinoma soft tissue sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Febrile neutropenia

Contacts and locations

Locations

  • Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center

    Cleveland, Ohio, 44106, United States

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