chemotherapy-induced peripheral neuropathy CIPN
Conditions
Interventions
The affected extremity or extremities will be treated with Qutenza (179mg)
according to normal procedures of the hospital and as recommended by the
manufacturer.
Patients randomized to duloxetine w
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years of age - Presence of CIPN grade 1 or higher according to the NCIC-CTC - Treatment with chemotherapy in the last 5 years - Able to give oral and written informed consent - Painful neuropathy with mean pain (1 week) score of >= 4
Exclusion criteria
Exclusion criteria: - Peripheral neuropathy from other causes (e.g. carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy) - Leptomeningeal carcinomatosis - Use of selective serotonin reuptake inhibitors, exchanging for medication without interaction is possible following expertise of the pain specialist anti-depressant medication - Psychiatric disorders which can interfere with cooperation - Abnormal renal ( 2 times normal value) - Severe heart failure as determined by the cardiologist - Allergy for duloxetine or capsaicin - Skin diseases in hands and/or feet, damaged skin - The presence of uncontrolled/untreated hypertension - Concomitant use of medication that may interact with duloxetine such as fluvoxamine, ciprofloxacin and enoxacin which is not replaceable and according to the treating specialist not safe to combine with duloxetine - Any condition that by the judgement of the investigator might interfere with the investigation - Previous treatment with Qutenza or duloxetine for CIPN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain severity at week 12 after start of treatment as measured by the NRS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Interference score (BPI) at week 6 and 12 2. Side effect profile at week 1,2,3,4,5 and 6 3. Quality of life (EQ-5D-5L) at week 6 and 12 4. Patient satisfaction (GPE) at week 1,2,3,4,5,6,8,10 and12 5. Pain score (NRS) at week Pain at 1,2,3,4,5,6, 8 and 10 weeks after the start of treatment | — |
Countries
Netherlands
Outcome results
None listed