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Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.

NCT04704453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-04-14

No results posted yet for this study

Summary

This study aims to compare the analgesic activity of capsaicin patch 8% applications at 3 months interval each on the cervico-facial area versus a reference neuropathic treatment with amitriptyline in patients with head and neck cancer in remission and with sequelae neuropathic pain.

In this phase II trial, patients will be assigned in one of the two treatment arms:

* Arm A (Experimental arm): Capsaïcin patch (Qutenza®)
* Arm B (standard arm): Amitriptyline (Laroxyl®)

130 patients will be included and will be followed during 9 months.

Conditions

Interventions

DRUG

Capsaïcin patch (Qutenza®)

Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).

DRUG

Amitriptyline (Laroxyl®)

Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily.

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2025-04-28
Completion
2025-04-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT04704453 on ClinicalTrials.gov