Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy

Last updated: February 28, 2025
Sponsor: University of Vermont
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Symptom Care at Home with NP follow up

Clinical Study ID

NCT04763356
REMOTECIPN1
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Age ≥ 18.

  2. Completion of taxane, platinum, vinca alkaloid-based chemotherapy, bortezomib,thalidomide, lenalidomide, ixazomib, or brentuximab vedotin for cancer in the last 540 days, or ongoing maintenance therapy with bortezomib, thalidomide, lenalidomideor ixazomib for > 90 days.

  3. Development of CIPN during or within 3 months of the most recently completedchemotherapy or previous neurotoxic chemotherapy for the same malignancy. Forpatients on ongoing maintenance therapy: Development of CIPN during currentneurotoxic chemotherapy with bortezomib, thalidomide, lenalidomide, ixazomibbrentuximab vendotin or vincristine. CIPN diagnosis will be based on clinicaldiagnosis and the Toronto Criteria for Probable Distal Symmetric Polyneuropathyincluding the upper and lower extremities. The Toronto Criteria for Probable Distal Symmetric Polyneuropathy is defined as acombination of symptoms and signs of neuropathy including:

  4. At least 1 (one) of the following neuropathic symptoms: "asleep numbness",prickling or stabbing, burning or aching pain AND

  5. At least 1 (one) of the following: decreased distal sensation, or unequivocallydecreased or absent ankle reflexes. (59) Clinical Diagnosis: a. Confirmation of CIPN diagnosis by CIPN expert (investigator/co-infestigator basedon chart review +/- inperson/virtual interview with examination).

  6. Presence of at least one positive neuropathic sensory symptom on the NTSS-6 rankedas moderate or severe on the day of screening or in the preceding week based onrecall.

  7. The ability to speak/ read sufficient English to be able to communicate with studyNP over the phone, utilize the App, website and phone tree (all of which are onlyavailable in English).

Exclusion

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Expected treatment with another neurotoxic chemotherapy within the 13 week overallstudy duration (For example, platinum, taxane, vinca alkaloid, thalidomide,brentuximab vedotin or related drug, or arsenic trioxide. This exclusion does notapply to continuation of treatment for patients on maintenance therapy as describedin the inclusion criteria).

  2. Presence of a neurological problem that would confound CIPN assessment (lumbar orcervical radiculopathy, or pre-existing neuropathy from another cause such asdiabetes).

  3. Currently receiving treatment at a pain clinic specifically for CIPN pain.

  4. Concurrent participation in a different CIPN or pain treatment trial.

  5. For women of childbearing potential: Current pregnancy

  6. For women of childbearing potential: Unwillingness to use and acceptable form ofbirth control for the duration of the study. Acceptable forms of birth controlinclude long acting implantable contraception (ie IUDs, Nexplanon), Oralcontraception pills, contraception injections, or strict abstinence if it is part ofthe subject's current lifestyle.

Study Design

Total Participants: 422
Treatment Group(s): 1
Primary Treatment: Symptom Care at Home with NP follow up
Phase:
Study Start date:
January 10, 2023
Estimated Completion Date:
July 31, 2026

Study Description

This is a prospective single blinded (outcome assessor) randomized controlled trial of a CIPN care model that pairs a personalized suite of remote symptom monitoring technologies with triggered real time responses from a nurse practitioner (NP) equipped to enact algorithmic guideline based CIPN treatment in response to poorly controlled symptoms. The study will enroll adult cancer patients who have, within the last 540 days, completed a course of a taxane, platinum, or vinca alkaloid-based agent, bortezomib, thalidomide, lenalidomide, ixazomib or brentuximab vedotin, or have been receiving ongoing maintenance therapy with bortezomib, thalidomide, lenalidomide or ixazomib for >90 days, and have been diagnosed with CIPN. Participants will log neuropathy symptoms daily for a one week run-in period using a remote symptom monitoring technology described below. Participants who meet the criteria to proceed in the study will be randomized in a 1:1 ratio to Usual Care (UC) or Symptom Care at Home with Nurse Practitioner follow up (SCH-NP). Those not meeting eligibility criteria will be excluded but can be rescreened 6 weeks later. Both groups will log symptoms daily and receive either UC or SCH-NP care for the 12 week study period.

The UC group will report daily neuropathy symptoms via the web, app or automated phone system and will receive usual care for CIPN symptoms from their existing treatment team. The SCH-NP group will report symptoms similarly but concerning symptoms will trigger a call back from a nurse practitioner who can provide treatment based on standardized algorithmic CIPN guidelines.

In person study visits will take place at baseline and 6 and 12 weeks after randomization. CIPN specific QoL and disability measures, validated CIPN sign scales and detailed information on opioids, neuropathic pain medications and other CIPN treatments will be collected at each visit.

Connect with a study center

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • University of Vermont

    Burlington, Vermont 05405
    United States

    Active - Recruiting

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

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