Qutenza Versus Duloxetine in Chemotherapy-induced Peripheral Neuropathy (CIPN)

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to determine whether in patients with CIPN pain, treatment with Qutenza has the same effect as treatment with duloxetine 60 mg daily.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: Leiden University Medical Center
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Age ≥ 18 years of age

• Presence of CIPN grade 1 or higher according to the NCIC-CTC

• Mean pain (1 week) score of ≥ 4

• Treatment with chemotherapy in the last 5 years to 3 months ago

• Able to give oral and written informed consent

• Painful neuropathy longer than three months

Exclusion Criteria:

• Peripheral neuropathy from other causes (e.g. carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy)

• Leptomeningeal carcinomatosis

• Severe depression or use of anti-depressant medication

• Psychiatric disorders which can interfere with cooperation

• Abnormal renal (< GFR 30) or liver function tests (> 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

• Active cancer treatment (such as radiotherapy or chemotherapy)

• Active cancer

• Previous treatment with Qutenza or duloxetine for CIPN

• Any condition that by the judgement of the investigator might interfere with the investigation