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Tricyclic Antidepressant

Experimental arm (A): capsaicin patch for Head and Neck Cancers (TEC-ORL Trial)

Phase 2
Recruiting
Research Sponsored by Institut Claudius Regaud
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months for each patient
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Head and Neck Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months for each patient
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for each patient for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard arm (B): amitriptylineExperimental Treatment1 Intervention
Group II: Experimental arm (A): capsaicin patchExperimental Treatment1 Intervention

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Who is running the clinical trial?

Institut Claudius RegaudLead Sponsor
113 Previous Clinical Trials
38,648 Total Patients Enrolled
~32 spots leftby Jan 2026
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