RECRUITING

Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy

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Conditions

Chemotherapy-induced Peripheral Neuropathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy

Quick Facts

Study Start:2023-01-10
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04763356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18.
  2. 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, lenalidomide or ixazomib for \> 90 days.
  3. 3. 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 or ixazomib. CIPN diagnosis will be based on clinical diagnosis and the Toronto Criteria for Probable Distal Symmetric Polyneuropathy including the upper and lower extremities.
  4. 1. At least 1 (one) of the following neuropathic symptoms: "asleep numbness", prickling or stabbing, burning or aching pain AND
  5. 2. At least 1 (one) of the following: decreased distal sensation, or unequivocally decreased or absent ankle reflexes. (59)
  6. 4. 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.
  7. 5. 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).
  1. 1. Expected treatment with another neurotoxic chemotherapy within the 13 week overall study duration (For example, platinum, taxane, vinca alkaloid, thalidomide, brentuximab vedotin or related drug, or arsenic trioxide. This exclusion does not apply to continuation of treatment for patients on maintenance therapy as described in the inclusion criteria).
  2. 2. Presence of a neurological problem that would confound CIPN assessment (lumbar or cervical radiculopathy, or pre-existing neuropathy from another cause such as diabetes).
  3. 3. Currently receiving treatment at a pain clinic specifically for CIPN pain.
  4. 4. Concurrent participation in a different CIPN or pain treatment trial.
  5. 5. For women of childbearing potential: Current pregnancy
  6. 6. 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.

Contacts and Locations

Study Contact

Noah A Kolb, MD
CONTACT
802-847-4589
noah.kolb@uvmhealth.org
Mary Healey
CONTACT
802-656-9427
Mary.healey@uvmhealth.org

Principal Investigator

Noah A Kolb, MD
PRINCIPAL_INVESTIGATOR
University of Vermont

Study Locations (Sites)

University of Utah
Salt Lake City, Utah, 84112
United States
University of Vermont
Burlington, Vermont, 05405
United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: University of Vermont

  • Noah A Kolb, MD, PRINCIPAL_INVESTIGATOR, University of Vermont

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-10
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-01-10
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chemotherapy-induced Peripheral Neuropathy