ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy (NCT06657183) | Clinical Trial Compass
RecruitingNot Applicable
ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy
United States30 participantsStarted 2025-08-06
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.