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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Sep 28, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments for pain caused by chemotherapy-induced peripheral neuropathy (CIPN), a condition that can occur after receiving chemotherapy. The study is testing whether a medication called Qutenza, which is a patch containing a substance from hot peppers, works as well as duloxetine, a commonly prescribed antidepressant that also helps with pain. The goal is to find out which treatment is more effective for managing this type of pain.

To participate in the trial, individuals must be at least 18 years old and have experienced painful neuropathy for more than three months. They should also have had chemotherapy within the last five years and have a pain score of 4 or higher on a scale of 0 to 10. However, certain conditions, like having neuropathy from other causes, severe depression, or active cancer treatment, may prevent someone from being eligible. Participants will receive either Qutenza or duloxetine and will be monitored to see how well their pain improves over time. This trial is currently recruiting and is open to all genders.

Gender

ALL

Eligibility 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
• • 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