Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Vermont
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
At least 1 (one) of the following neuropathic symptoms: "asleep numbness", prickling or stabbing, burning or aching pain AND
Disqualifiers
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).
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Symptom Care at Home with NP follow up
Other interventionIn 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.
Treatment groups
422 Participants
are divided into 2 treatment groupsGroup A: Usual Care (UC)No intervention 0 interventions
Group B: SCH with NP follow-up (SCH-NP)Experimental treatment 1 intervention
Trial outcomes
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
Time frame
12 week study periodSecondary outcomes
1
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Chemotherapy Induced Peripheral Neuropathy 20 (EORTC- CIPN 20):
The EORTC CIPN 20 is a 20 item CIPN specific quality of life PRO. Scores range from 20 to 80 with higher scores denoting a worse outcome.
Time frame
baseline, 6 weeks, 12 weeks2
The % of participants taking ≥ 50 morphine milligram equivalents (MME)/ day
MME/day is the CDC recommended method of measuring and comparing opiate use
Time frame
baseline, 6 weeks, 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Vermont
Lead sponsor
Virginia Commonwealth University
Collaborator
University of Utah
Collaborator
Source ClinicalTrials.gov