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

December 11, 2023 updated by: Emma Cassee, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC, Locatie VUMC
        • Contact:
          • Emma Cassee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with chemotherapy-induced peripheral neuropathy who receive Qutenza
Drug: 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.
Active Comparator: Patients with chemotherapy-induced peripheral neuropathy who receive Duloxetine
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain interference score
Time Frame: 12 weeks
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
12 weeks
Quality of life score
Time Frame: 12 weeks
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
12 weeks
Side effect profile
Time Frame: 12 weeks
Measured by patient diary, open to fill in what side effects patients experienced
12 weeks
Patient satisfaction
Time Frame: 12 weeks
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
12 weeks
Pain at 6 weeks after the start of treatment
Time Frame: 6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Leiden University Medical Center
Reinier de Graaf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL79669.029.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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