Chemotherapy-induced polyneuropathy nerve pain
Conditions
Interventions
Treatment with duloxetine or lacosamide for 8 weeks.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age> 18 years 2. Able to give oral and written informed consent 3. Presence of CIPN grade 1 or higher according to the NCIC-CTC 4. Pain score of 4 or higher 5. Chemotherapy with taxanes, platinums, vincalkinioids or bortezomib in the past 6. Presence of symptoms of neuropathic pain at least 3 months after the last chemotherapy
Exclusion criteria
Exclusion criteria: 1. Allergy to the study medication 2. Epilepsy 3. History of illicit drug or alcohol abuse 4. History of psychosis 5. Pregnancy or lactation 6. Use of anti-epileptic or anti-depressant medication (in particular MAO inhibitors) 7. Use of CYP1a2 inhibitors (e.g. fluvoxamine, fluocinolone, cimetidine) 8. Concomitant neuropathy other than chemotherapy-induced 9. Moderate and severe liver enzyme abnormalities 10. Kidney dysfunction (GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To explore the analgesic effect of lacosamide compared to duloxetine in patients with painful chemotherapy-induced polyneuropathy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): 1. To assess the side effect profile of lacosamide and duloxetine 2. To phenotype patients with painful chemotherapy-induced polyneuropathy using quantitative sensory testing, conditioned pain modulation, offset analgesia and cornea confocal microscopy 3. To correlate the CIPN phenotype of patients with the treatment effect of lacosamide and duloxetine. | — |
Countries
Netherlands
Outcome results
None listed