Actively Recruiting
Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy
Led by University of Vermont · Updated on 2026-03-10
422
Participants Needed
3
Research Sites
194 weeks
Total Duration
On this page
Sponsors
U
University of Vermont
Lead Sponsor
V
Virginia Commonwealth University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective randomized trial designed to investigate a new care model for patients who suffer from nerve damage from chemotherapy called chemotherapy induced peripheral neuropathy (CIPN). All participants in the study will report their CIPN symptoms daily using a website, app or phone for 12 weeks. In one group the data will be collected and participants will be encouraged to reach out to their treating doctors for uncontrolled symptoms. These participants' doctors can prescribe any treatment they feel is appropriate. In the second group, if the symptoms meet the criteria for eligibility they will receive a phone call from a nurse practitioner either the same day or next day, depending on the time symptoms were logged. That nurse practitioner will determine the correct CIPN treatment using an algorithm and prescribe it. The study will track the severity of symptoms over time as well as looking at the impact on treatments for CIPN (medications and referrals).
CONDITIONS
Official Title
Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Completed chemotherapy with taxane, platinum, vinca alkaloid-based agents, bortezomib, thalidomide, lenalidomide, ixazomib, or brentuximab vedotin within the last 540 days, or ongoing maintenance therapy with bortezomib, thalidomide, lenalidomide, or ixazomib for more than 90 days
- Developed chemotherapy-induced peripheral neuropathy (CIPN) during or within 3 months after the most recent chemotherapy or during ongoing maintenance therapy
- CIPN diagnosis confirmed clinically and by Toronto Criteria for Probable Distal Symmetric Polyneuropathy
- At least one moderate or severe neuropathic sensory symptom on the NTSS-6 within the past week
- Ability to read and speak English well enough to communicate with the study nurse practitioner and use reporting tools
You will not qualify if you...
- Expected to receive another neurotoxic chemotherapy during the 13-week study period (except maintenance therapy continuation)
- Presence of neurological conditions that interfere with CIPN assessment, such as lumbar or cervical radiculopathy or neuropathy from other causes like diabetes
- Currently receiving treatment at a pain clinic specifically for CIPN pain
- Participating in another CIPN or pain treatment trial
- Current pregnancy for women of childbearing potential
- Unwillingness to use acceptable birth control methods during the study for women of childbearing potential
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
2
University of Vermont
Burlington, Vermont, United States, 05405
Actively Recruiting
3
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
N
Noah A Kolb, MD
CONTACT
M
Mary Healey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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