Chemotherapy induced polyneuropathy (CIPN)
Conditions
Interventions
Lacosamide vs Duloxetine
Sponsors
LUMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age> 18 years 2. Able to give oral and written informed consent 3. Indications of small- or large fiber neuropathy with quantitative sensory testing (compared to healthy population) 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 for at least 6 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 < 30 mL/min) 11. Severe heart failure (e.g. as a result of infarction or a structural heart defect) 12. 2nd or 3rd degree atrioventricular (AV) block and sodium channelopathies. 13. Systolic blood pressure above 180mm Hg with current antihypertensive medications (according to screening measurement) 14. Any condition that by the judgement of the investigator might interfere with the investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To explore the analgesic effect of lacosamide compared to duloxetine in patients with painful chemotherapy-induced polyneuropathy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactCornelis Jan van Dam
Leiden University Medical Center
Outcome results
None listed