Clinical trial
A Comparison Between Qutenza and Duloxetine for the Treatment of Painful Chemotherapy-induced Peripheral Neuropathy: a Pragmatic Randomized Controlled Trial
Name
NL79669.029.21
Description
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.
Trial arms
Trial start
2022-12-01
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Recruiting
Treatment
Qutenza
Capsaicine patch: Qutenza 8% patch will be applied to the skin according to the instruction of the manufacturer. After application of local anesthetics on the skin, a Qutenza 8% patch will be placed. 1-4 patches will be placed and can be adjusted to the right size, depending on the surface of the CIPN. The patch(es) will be removed after 30-60 minutes. The effect will last about 12 weeks.
Arms:
Patients with chemotherapy-induced peripheral neuropathy who receive Qutenza
Duloxetine
Duloxetine tablets: In week 1 patients will receive 30 mg duloxetine one time per day. In week 2 the dose will be increased to 60 mg one time per day. In case of inacceptable adverse events the patient is allowed to reduce the dose to 30 mg one time per day after consultation with the researcher or physician.
Arms:
Patients with chemotherapy-induced peripheral neuropathy who receive Duloxetine
Size
102
Primary endpoint
Average pain change
12 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 102, 'type': 'ESTIMATED'}}
Updated at
2023-12-15
1 organization
2 products
4 indications
Product
QutenzaIndication
ZostrixIndication
DuloxetineIndication
Peripheral neuropathyProduct
Duloxetine