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Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy

NCT04763356 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2026-03-10

No results posted yet for this study

Summary

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

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

OTHER

Symptom Care at Home with NP follow up

In the SCH-NP group all participants will report their CIPN related symptoms daily via the app, website or phone tree. Any concerning symptoms will trigger a call back from a nurse practitioner who will use a consensus and evidence based algorithm to prescribe therapies for the CIPN symptoms.

Sponsors & Collaborators

  • Virginia Commonwealth University

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • University of Vermont

    lead OTHER

Principal Investigators

  • Noah A Kolb, MD · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04763356 on ClinicalTrials.gov