NCT06657183 · Case Comprehensive Cancer Center
ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy
What this study is about
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™.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations