ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy

NCT06657183 | Recruiting DMC FDA Device

• 1 other identifier: CASE4124
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Undergoing cancer treatment comes with various risks and side effects. This clinical trial aims to reduce those risks and side effects through continuous monitoring of vital signs and blood levels. The goal is to see if potential side effects can be identified and treated sooner. During this study, participants will wear an Alio Smartpatch™. The Alio Smartpatch™ is a wireless remote monitoring system. This device will measure participants' vital signs and blood levels. Participants will also be asked to use continuous glucose monitors to measure their glucose levels. The data collected on each participant from these devices will be remotely monitored at all times by clinical staff at a company known as Quantify Remote Care. If a participant's results look like they are experiencing a side effect, the participant will be contacted immediately by Quantify Remote Care team. The Quantify Remote Care team will function as an extension of the participant's cancer clinical team and will relay any significant issues back to them. Quantify Health also provides dietary and mental health support as needed for all participants.

Conditions

Febrile Neutropenia

Keywords

Alio Smart Patch

Outcome Measures

Primary Outcomes (1)

• Participant compliance

  Rate of participant compliance will be measured. Alio Smartpatch Compliance is defined as \>=80% daily use, reflecting participant adherence to the prescribed monitoring regimen.

  Up to 12 weeks from entering study

Secondary Outcomes (6)

• Identification of febrile neutropenia symptoms

  Up to 13 weeks from entering study

• Participant satisfaction: Usability

  Up to 13 weeks from entering study

• Participant satisfaction: Comfort

  Up to 13 weeks from entering study

• Participant satisfaction: Overall Experience

  Up to 13 weeks from entering study

• Clinical effectiveness of the integrated QRC ECM and smartpatch as measured by frequency of emergency care

  Up to 13 weeks from entering study

Study Arms (1)

Remote Monitoring with Smartpatch

EXPERIMENTAL

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

Device: Alio Smart Patch™

Interventions

Alio Smart Patch™ DEVICE

Alio Smart Patch is a non-invasive wearable biosensor that combines a unique, multi-sensor, wearable device with a provided- based portal to track sequentially the participant's physiologic, hematologic and electrolyte data. It works in conjunction with a home hub data relay system and an end-to-end cloud software data path. The system has been developed to enable home monitoring for multiple key metrics by healthcare provider caring for participants. Enhanced Care Management (ECM) is a comprehensive, system-centric approach crafted to bridge the latent gaps in traditional care paradigms. ECM provides an exhaustive review of a participant's medical history and their personalized social needs, addressing both in a cohesive, participant-focused strategy. This intervention couples Quantify Remote Care's Enhanced Care Management with the Alio Smart Patch technology.

Remote Monitoring with Smartpatch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Alberto Montero, MD, MBA

  Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Montero, MD, MBA

CONTACT

216-844-3951; Alberto.Montero@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 24, 2024
• Study Start: August 6, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)