QutenzaQULOXNCT05560516
Qutenza Versus Duloxetine in Chemotherapy-induced Peripheral Neuropathy (CIPN)
A study testing Qutenza and Duloxetine in people with Qutenza and Duloxetine, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Qutenza, Duloxetine, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Qutenza and Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, locatie VUMC
Amsterdam
Emma Cassee
About this study
Official title: A Comparison Between Qutenza and Duloxetine for the Treatment of Painful Chemotherapy-induced Peripheral Neuropathy: a Pragmatic Randomized Controlled Trial
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.
Read the detailed description
Rationale: Painful polyneuropathy occurs in approximately 20-40% of patients after the chemotherapy treatment and has a negative influence on quality of life. To our knowledge, no previous randomized study examined Qutenza in patients with CIPN, and no study compared Qutenza to duloxetine. We hypothesize that the effect of Qutenza on the severity of pain and its impact on functioning is the same as that of duloxetine in patients with CIPN, as measured by the numeric rating scale (NRS).
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
- Qutenza, Duloxetine, Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Being tested
- Qutenza, Duloxetine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QutenzaDrug
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.
DuloxetineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chemotherapy-induced peripheral neuropathy who receive Qutenza | Experimental | Not described Receives: Drug: Qutenza |
| Patients with chemotherapy-induced peripheral neuropathy who receive Duloxetine | Active comparator | Not described Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain change
As measured by the Brief Pain Inventory, a scale from 0 to 10, with 0 is no pain at all, and 10 is worst pain you can imagine
Measured: 12 weeks
Secondary outcomes (5)
Pain interference score
Measured by the Brief Pain Inventory, a scale from 0 to 10, with 0 is no pain at all, and 10 is worst pain you can imagine
Measured: 12 weeks
Quality of life score
Measured by EuroQol-5D-5L: The descriptive system comprises 5 dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions
Measured: 12 weeks
Side effect profile
Measured by patient diary, open to fill in what side effects patients experienced
Measured: 12 weeks
Patient satisfaction
Measured by Global perceived effect score, a scale from 1 to 7, with recovery scale 1 means much better and 7 means pain got worse
Measured: 12 weeks
Pain at 6 weeks after the start of treatment
Measured by Brief Pain Inventory, a scale from 0 to 10, with 0 is no pain at all, and 10 is worst pain you can imagine
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QutenzaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Reinier de Graaf Groep
- Responsible party
- Principal investigator, Emma Cassee, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560516
- Sponsor's protocol ID
- NL79669.029.21
- Acronym
- QULOX
- Status last verified
- Dec 2023
- First submitted
- 15 Aug 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Qutenza and Duloxetine for the Treatment of Painful Chemotherapy-induced Peripheral Neuropathy: a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05560516
- Acronym / sponsor ID
- QULOX / NL79669.029.21
- Conditions
- Qutenza, Duloxetine, Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Leiden University Medical Center, Reinier de Graaf Groep
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Painful polyneuropathy occurs in approximately 20-40% of patients after the chemotherapy treatment and has a negative influence on quality of life. To our knowledge, no previous randomized study examined Qutenza in patients with CIPN, and no study compared Qutenza to duloxetine. We hypothesize that the effect of Qutenza on the severity of pain and its impact on functioning is the same as that of duloxetine in patients with CIPN, as measured by the numeric rating scale (NRS).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chemotherapy-induced peripheral neuropathy who receive Qutenza | Experimental | Drug: Qutenza |
| Patients with chemotherapy-induced peripheral neuropathy who receive Duloxetine | Active comparator | Drug: Duloxetine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QutenzaCapsaicine 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. | Drug | Patients with chemotherapy-induced peripheral neuropathy who receive Qutenza |
| DuloxetineDuloxetine 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. | Drug | Patients with chemotherapy-induced peripheral neuropathy who receive Duloxetine |
Primary outcome
Average pain change
Time frame: 12 weeks
As measured by the Brief Pain Inventory, a scale from 0 to 10, with 0 is no pain at all, and 10 is worst pain you can imagine
5 secondary outcomes
Pain interference score
Time frame: 12 weeks
Quality of life score
Time frame: 12 weeks
Side effect profile
Time frame: 12 weeks
Patient satisfaction
Time frame: 12 weeks
Pain at 6 weeks after the start of treatment
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qutenza and Duloxetine in people with Qutenza and Duloxetine, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Cassee (+31643949251, e.cassee@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain change (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.