Qutenza Versus Duloxetine in Chemotherapy-induced Peripheral Neuropathy (CIPN)
NCT ID: NCT05560516
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
102 participants
INTERVENTIONAL
2022-12-01
2025-12-31
Brief Summary
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Detailed Description
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Objective: 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.
Study design: The study is a pragmatic randomized controlled trial.
Study population: Patients who have been treated with chemotherapy in the last 5 years to 3 months and with CIPN grade 1 or higher according to the NCIC-CTC (National Cancer Institute of Canada-Common Toxicity Criteria). The patients are ≥ 18 years of age and have to experience painful neuropathy longer than 3 months with mean (1 week) pain score of ≥4.
Intervention: 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 will start with duloxetine 30 mg per day. After 1 week the dose of duloxetine will be increased, if tolerated, to 60 mg per day for a period of 12 weeks.
Main study parameters/endpoints: The primary endpoint will be average pain reduction at week 12 after start of treatment as measured by the NRS (Numeric Rating Scale). Furthermore secondary objectives will be: pain interference as measured by the BPI (Brief Pain Inventory), side effect profile, quality of life, patient satisfaction, pain at 6 weeks after the start of treatment.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will visit the research location for a screening visit to determine whether the patient fits the in- and exclusion criteria. After the baseline visit patients will be randomized to either receive Qutenza or duloxetine.
All patients will fill in questionnaires (either digital or on paper) before starting treatment with Qutenza or duloxetine (T=0), after 6 weeks of treatment (T=6) and after 12 weeks of treatment (T=12) to obtain the primary and secondary endpoints. All patients will be followed for a total period of 12 weeks. In the first week of treatment patients fill in a questionnaire with side effect profile on a daily basis after 2 weeks patients will fill in a questionnaire on a weekly base. Castor will be used to send the 'side effect questionnaire'.
Since both treatments are commonly used in the treatment of neuropathic pain and are both registered for that indication, no serious complications and no additional burden other than normal treatment are expected.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Patients with chemotherapy-induced peripheral neuropathy who receive Qutenza
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.
Patients with chemotherapy-induced peripheral neuropathy who receive Duloxetine
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Reinier de Graaf Groep
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Emma Cassee, MD
Coordinating investigator/project leader
Locations
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Amsterdam UMC, locatie VUMC
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Emma Cassee
Role: primary
Related Links
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Other Identifiers
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NL79669.029.21
Identifier Type: -
Identifier Source: org_study_id