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

NCT05560516 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2023-12-15

No results posted yet for this study

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.

Conditions

  • Qutenza
  • Duloxetine
  • Chemotherapy-induced Peripheral Neuropathy
  • CIPN - Chemotherapy-Induced Peripheral Neuropathy

Interventions

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.

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.

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Reinier de Graaf Groep

    collaborator OTHER

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560516 on ClinicalTrials.gov