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

NCT04704453 | Completed Phase 2

• 1 other identifier: 20 VADS 04
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief 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

Head and Neck Cancer

Keywords

Neuropathic Pain; Capsaicin patch; Amitriptyline

Outcome Measures

Primary Outcomes (1)

• The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.

  Pain will be assessed using a numerical scale from 0 to 10.

  9 months for each patient

Secondary Outcomes (3)

• Neuropathic pain according to the Neuropathic Pain Symptom Inventory (NPSI) questionnaire.

  9 months for each patient

• Adverse events of the drugs evaluated using the NCI-CTC AE V5.

  9 months for each patient

• Quality of life evaluated according to the Quality of Life Questionnaire-Core 30 (QLQ-C30).

  9 months for each patient

Study Arms (2)

Experimental arm (A): capsaicin patch

EXPERIMENTAL

Drug: Capsaïcin patch (Qutenza®)

Standard arm (B): amitriptyline

OTHER

Drug: Amitriptyline (Laroxyl®)

Interventions

Capsaïcin patch (Qutenza®) DRUG

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

Experimental arm (A): capsaicin patch

Amitriptyline (Laroxyl®) DRUG

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

Standard arm (B): amitriptyline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• ORL cancer in remission: absence of clinical or radiological signs of progression at least 3 months after specific treatments.
• Pain of the cervico-facial sphere persisting for more than 3 months after surgical and/or radiotherapy treatment.
• Peripheral neuropathic character of pain objectified to a score ≥ 4/10 on the DN4 questionnaire.
• Pain whose average intensity over the last 24 hours is assessed on the numerical scale as ≥ 2/10.
• Patient affiliated to a Social Health Insurance in France.

You may not qualify if:

• ORL cancer in progression.
• Other concomitant neoplasia (progressive or not).
• Central etiology of pain.
• Pain whose average intensity over the last 24 hours is assessed on the numerical scale as \< 2/10.
• Allergy to any of the components of the capsaicin patch.
• Capsaicin patch not applicable to the area to be treated despite the precautions described in the protocol because of its proximity to mucous membranes or eyelids.
• Contraindication to amitriptyline treatment.
• Patient with an unhealed skin lesion on the area to be treated.
• Previous treatment with capsaicin or amitriptyline.
• Ongoing opioid treatment \> 80mg/day oral morphine equivalent.
• Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago.
• Patient included in another interventional therapeutic trial.
• Pregnant or breastfeeding patient.
• Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
• Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (4)

INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers

Angers, France

Location

Institut Sainte-Catherine

Avignon, France

Location

Hôpital Saint-Joseph

Marseille, 13285, France

Location

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31059, France

Location

Related Publications (1)

• Boden A, Lusque A, Lodin S, Bourgouin M, Mauries V, Moreau C, Fabre A, Mounier M, Poublanc M, Caunes-Hilary N, Filleron T. Study protocol of the TEC-ORL clinical trial: a randomized comparative phase II trial investigating the analgesic activity of capsaicin vs Laroxyl in head and neck Cancer survivors presenting with neuropathic pain sequelae. BMC Cancer. 2022 Dec 5;22(1):1260. doi: 10.1186/s12885-022-10348-2.

  PMID: 36471253 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Neuralgia

Interventions

Capsaicin; Amitriptyline

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 11, 2021
• Study Start: April 28, 2021
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (4)