Phase
Condition
Neurologic Disorders
Treatment
Symptom Care at Home with NP follow up
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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, lenalidomideor ixazomib for > 90 days.
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:
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 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).
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.
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:
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).
Presence of a neurological problem that would confound CIPN assessment (lumbar orcervical radiculopathy, or pre-existing neuropathy from another cause such asdiabetes).
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 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
Study Description
Connect with a study center
University of Utah
Salt Lake City, Utah 84112
United StatesActive - Recruiting
University of Vermont
Burlington, Vermont 05405
United StatesActive - Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23298
United StatesActive - Recruiting
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