Comparing Qutenza and Duloxetine for treating chemotherapy-induced nerve pain
A Comparison Between Qutenza and Duloxetine for the Treatment of Painful Chemotherapy-induced Peripheral Neuropathy: a Pragmatic Randomized Controlled Trial
This study is testing whether a skin treatment called Qutenza works better than the oral medication duloxetine for relieving nerve pain caused by chemotherapy in patients who have been suffering for over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05560516 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Qutenza, a topical treatment, with duloxetine, an oral medication, in alleviating pain from chemotherapy-induced peripheral neuropathy (CIPN). The study will involve patients who have experienced painful neuropathy for over three months following chemotherapy. Participants will be randomly assigned to receive either Qutenza or duloxetine, with the latter starting at a lower dose and potentially increasing based on tolerance. The primary outcome will be measured using a numeric rating scale to assess pain severity and its impact on daily functioning.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced CIPN pain for more than three months and have a pain score of 4 or higher.
Not a fit: Patients with peripheral neuropathy from causes other than chemotherapy or those with severe psychiatric or medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative treatment for patients suffering from CIPN pain.
How similar studies have performed: While no previous studies have directly compared Qutenza to duloxetine in CIPN, the approach of using Qutenza for neuropathic pain is novel and untested in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam
- Amsterdam UMC, locatie VUMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Emma Cassee
- Email: e.cassee@amsterdamumc.nl
- Phone: +31643949251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.