NCT05560516

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

August 15, 2022

Last Update Submit

December 11, 2023

Conditions

QutenzaDuloxetineChemotherapy-induced Peripheral NeuropathyCIPN - Chemotherapy-Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (5)

  • Pain interference score

    12 weeks

  • Quality of life score

    12 weeks

  • Side effect profile

    12 weeks

  • Patient satisfaction

    12 weeks

  • Pain at 6 weeks after the start of treatment

    6 weeks

Study Arms (2)

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

Interventions

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.

Patients with chemotherapy-induced peripheral neuropathy who receive Qutenza
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.

Patients with chemotherapy-induced peripheral neuropathy who receive Duloxetine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, locatie VUMC

Amsterdam, Netherlands

RECRUITING

Related Links

MeSH Terms

Interventions

CapsaicinDuloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsThiophenesSulfur CompoundsHeterocyclic Compounds, 1-Ring

Central Study Contacts

Emma Cassee

CONTACT

+31643949251e.cassee@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating investigator/project leader

Study Record Dates

First Submitted

August 15, 2022

First Posted

September 29, 2022

Study Start

December 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)