Alio Smartpatch continuous monitoring for chemotherapy patients to catch febrile neutropenia early
Enhanced Care Management (ECM) and Continuous Monitoring of Vital Signs With Alio Smart Patch Wearable Sensor in Adult Cancer Patients Receiving Chemotherapy With Moderate or High Risk of Febrile Neutropenia or Immunotherapy
This project will try having people on chemotherapy wear an Alio Smartpatch and a glucose monitor to see if continuous remote monitoring finds febrile neutropenia and other side effects sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06657183 on ClinicalTrials.gov |
What this trial studies
Participants with certain solid tumors who are starting new chemotherapy will wear an Alio Smartpatch™ and continuous glucose monitors that record vital signs and select blood-level metrics. Data from these devices are streamed to Quantify Remote Care clinical staff who monitor continuously and will contact the participant and their cancer care team if concerning changes are detected. The approach aims to move from patient-initiated reporting to proactive detection of febrile neutropenia and other chemotherapy-related complications. Enrollment is centered at Case Comprehensive Cancer Center / University Hospitals Cleveland Seidman Cancer Center and focuses on patients at higher risk for febrile neutropenia.
Who should consider this trial
Good fit: Adults with soft tissue sarcoma, non-small cell lung cancer, head and neck squamous cell carcinoma, breast, pancreatic cancer, or melanoma who are starting a new chemotherapy regimen and have high or intermediate risk factors for febrile neutropenia are ideal candidates.
Not a fit: Patients not receiving chemotherapy, those at low risk for febrile neutropenia, or people unable or unwilling to wear continuous monitoring devices or participate in remote follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, earlier detection could lead to faster treatment, fewer severe infections, and fewer hospital visits.
How similar studies have performed: Previous wearable monitoring studies in oncology have shown mixed feasibility and some signals that continuous patient-generated data can detect deterioration earlier, but adherence and workflow challenges have limited definitive proof.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Alberto Montero, MD, MBA — Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center
- Study coordinator: Alberto Montero, MD, MBA
- Email: Alberto.Montero@UHhospitals.org
- Phone: 216-844-3951
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.