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

Launched by CASE COMPREHENSIVE CANCER CENTER · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor patients with certain types of cancer who are receiving chemotherapy. The goal is to reduce the risks and side effects that can occur during treatment. Participants in this study will wear a device called the Alio Smartpatch™, which will continuously track their vital signs and blood levels. They will also use continuous glucose monitors to keep an eye on their blood sugar. The data collected will be monitored remotely by a team from Quantify Remote Care, who will alert participants and their doctors if any concerning changes occur. Additionally, the team will provide support for dietary and mental health needs throughout the study.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with specific types of cancer, such as breast or lung cancer. They should be starting a new chemotherapy treatment that poses a high risk for a complication called febrile neutropenia, which is a drop in white blood cells that can lead to fever and infections. Participants will need to be able to read or speak English and have access to a cellphone for communication. This trial is not yet recruiting, but it aims to help improve the safety and comfort of patients undergoing cancer treatment.

Gender

ALL

Eligibility 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