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

Head and Neck Cancer Clinical Trial

— TEC-ORL  

Official title:

Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04704453
• Other study ID #: 20 VADS 04
• Status: Recruiting
• Phase: Phase 2
• Start date: April 28, 2021
• Est. completion date: January 2026

Study information

• Verified date: July 2023
• Source: Institut Claudius Regaud
• Contact: Antoine BODEN
• Phone: 05 31 15 57 91
• Email: boden.antoine[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years.

2. ORL cancer in remission: absence of clinical or radiological signs of progression at least 3 months after specific treatments.

3. Pain of the cervico-facial sphere persisting for more than 3 months after surgical and/or radiotherapy treatment.

4. Peripheral neuropathic character of pain objectified to a score = 4/10 on the DN4 questionnaire.

5. Pain whose average intensity over the last 24 hours is assessed on the numerical scale as = 2/10.

6. Postmenopausal patient or patient who agrees to use effective contraception for the duration of treatment and for a minimum of 15 days after the end of the treatment period. Non-menopausal patients must have a negative pregnancy test prior to inclusion in the study.

7. Patient affiliated to a Social Health Insurance in France.

8. Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria:

1. ORL cancer in progression.

2. Other concomitant neoplasia (progressive or not).

3. Central etiology of pain.

4. Pain whose average intensity over the last 24 hours is assessed on the numerical scale as < 2/10.

5. Allergy to any of the components of the capsaicin patch.

6. 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.

7. Contraindication to amitriptyline treatment.

8. Patient with an unhealed skin lesion on the area to be treated.

9. Previous treatment with capsaicin or amitriptyline.

10. Topical treatment of the painful area used for more than 21 days before inclusion.

11. Ongoing opioid treatment > 80mg/day oral morphine equivalent.

12. Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago.

13. Patient included in another interventional therapeutic trial.

14. Pregnant or breastfeeding patient.

15. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.

16. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Neuralgia

Intervention

Drug:
• Capsaïcin patch (Qutenza®)
Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).
• Amitriptyline (Laroxyl®)
Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily.

Locations

Country	Name	City	State
France	INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers	Angers
France	Institut Sainte-Catherine	Avignon
France	Hôpital Saint-Joseph	Marseille
France	Institut Universitaire du Cancer Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neuropathic pain according to the Neuropathic Pain Symptom Inventory (NPSI) questionnaire.		9 months for each patient
Secondary	Adverse events of the drugs evaluated using the NCI-CTC AE V5.		9 months for each patient
Secondary	Quality of life evaluated according to the Quality of Life Questionnaire-Core 30 (QLQ-C30).		9 months for each patient