Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04763356

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered 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

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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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