Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy

NCT04763356 | Recruiting

• 1 other identifier: REMOTECIPN1
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• The change in NTSS-6 between the run-in and the 12 week study period.

  The Neuropathy Total Symptoms Score is a the NTSS- 6, a well validated patient reported neuropathy specific outcome measure. Scores range from 0 to 21.96. Higher scores denote worse outcomes

  12 week study period

Secondary Outcomes (2)

• Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Chemotherapy Induced Peripheral Neuropathy 20 (EORTC- CIPN 20):

  baseline, 6 weeks, 12 weeks

• The % of participants taking ≥ 50 morphine milligram equivalents (MME)/ day

  baseline, 6 weeks, 12 weeks

Study Arms (2)

Usual Care (UC)

NO INTERVENTION

The UC group (control) models the current standard of care model. The NTSS-6 will be completed daily by participants using the SCH system. The results will not be reported to their oncology team. Participants will be counseled at study entry to contact their treating care team to manage CIPN symptoms. They will also receive a reminder to do so at the end of each reporting session. UC participants will attend all regular visits with these providers and can receive any type of treatment for their CIPN symptoms. There are no limitations on the therapies that can be prescribed, or the means by which the clinical team communicates with the participant. Treating physicians will be provided with links to the current ASCP and NCCN guidelines but will not be provided with the algorithm as this group is meant to reflect current standard medical practice.

SCH with NP follow-up (SCH-NP)

EXPERIMENTAL

Participants will report daily symptom as above. The SCH system will notify the study NP for any of the following symptoms measured by the NTSS6: aching, allodynia, burning, lancinating, numbness, and prickling that are concerning. Participants will receive a NP call back either the same day or the next day, depending on the time they reported their symptoms. The NP will follow a standardized script to elicit details about the CIPN symptoms and recommend and prescribe CIPN treatment per the treatment algorithm.

Other: Symptom Care at Home with NP follow up

Interventions

Symptom Care at Home with NP follow up OTHER

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.

SCH with NP follow-up (SCH-NP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Age ≥ 18.
• 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, lenalidomide or ixazomib for \> 90 days or ongoing survival, palliative or equivalent therapy with any of the above listed drugs for \>90 days.
• Development of CIPN during or within 3 months of the most recently completed chemotherapy or previous neurotoxic chemotherapy for the same malignancy. For patients on ongoing maintenance therapy: Development of CIPN during current neurotoxic chemotherapy with bortezomib, thalidomide, lenalidomide, ixazomib brentuximab vendotin or vincristine. CIPN diagnosis will be based on clinical diagnosis and the Toronto Criteria for Probable Distal Symmetric Polyneuropathy including the upper and lower extremities.
• The Toronto Criteria for Probable Distal Symmetric Polyneuropathy is defined as a combination of symptoms and signs of neuropathy including:
• At least 1 (one) of the following neuropathic symptoms: "asleep numbness", prickling or stabbing, burning or aching pain AND
• At least 1 (one) of the following: decreased distal sensation, or unequivocally decreased or absent ankle reflexes. (59)
• Clinical Diagnosis:
• a. Confirmation of CIPN diagnosis by CIPN expert (investigator/co-infestigator based on chart review +/- inperson/virtual interview with examination).
• Presence of at least one positive neuropathic sensory symptom on the NTSS-6 ranked as moderate or severe on the day of screening or in the preceding week based on recall.
• The ability to speak/ read sufficient English to be able to communicate with study NP over the phone, utilize the App, website and phone tree (all of which are only available in English).

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Presence of a neurological problem that would confound CIPN assessment (lumbar or cervical radiculopathy, or pre-existing neuropathy from another cause such as diabetes).
• Currently receiving treatment at a pain clinic specifically for CIPN pain.
• Concurrent participation in a different CIPN or pain treatment trial.
• For women of childbearing potential: Current pregnancy
• For women of childbearing potential: Unwillingness to use and acceptable form of birth control for the duration of the study. Acceptable forms of birth control include long acting implantable contraception (ie IUDs, Nexplanon), Oral contraception pills, contraception injections, or strict abstinence if it is part of the subject's current lifestyle.

Sponsors & Collaborators

• University of Utah: collaborator
• University of Vermont: lead
• Virginia Commonwealth University: collaborator

Study Sites (3)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Vermont

Burlington, Vermont, 05405, United States

RECRUITING

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

• Noah A Kolb, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah A Kolb, MD

CONTACT

802-847-4589; noah.kolb@uvmhealth.org

Mary Healey

CONTACT

802-656-9427; Mary.healey@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor grading the only reported outcome measure (mTCNS) will be blinded to the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single blinded (outcome assessor) randomized controlled trial with 2 arms.

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: January 10, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)