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

Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With ORL Cancer in Remission and With Sequellae Neuropathic Pain. - TEC-ORL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003965-21-FR

Enrollment

130

Registered

2020-10-22

Start date

2021-01-11

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Qutenza® Pharmaceutical Form: Cutaneous patch Trade Name: Laroxyl® Pharmaceutical Form: Oral solution

Eligibility

Sex/Gender

All

Inclusion criteria

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.Patient affiliated to a Social Health Insurance in France. 7.Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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 80mg/day oral morphine equivalent. 11.Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago. 12.Patient included in another interventional therapeutic trial . 13.Pregnant or breastfeeding patient. 14.Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol. 15.Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 ORL cancer in remission and with neuropathic pain.;Secondary Objective: The secondary objectives of the study are : - A sensitivity study to assess the influence of managing pain other than neuropathic pain - Compare safety and tolerance between treatment arms - To compare the evolution of neuropathic pain between treatment arms - Compare quality of life between treatment arms;Primary end point(s): The Primary Outcome Measure is the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion. ;Timepoint(s) of evaluation of this end point: 9 months for each patient	—

Measure

Time frame

Main Objective: 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 ORL cancer in remission and with neuropathic pain.;Secondary Objective: The secondary objectives of the study are : - A sensitivity study to assess the influence of managing pain other than neuropathic pain - Compare safety and tolerance between treatment arms - To compare the evolution of neuropathic pain between treatment arms - Compare quality of life between treatment arms;Primary end point(s): The Primary Outcome Measure is the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion. ;Timepoint(s) of evaluation of this end point: 9 months for each patient

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Secondary

Measure	Time frame
Secondary end point(s): The Secondary Outcome Measures are: - For the sensitivity analysis, the endpoint will be defined as 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. Patients for whom pain management would be modified from the protocol will be considered failures. Patients with missing data for pain progression will be considered failures. - Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014). - Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5. - Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.;Timepoint(s) of evaluation of this end point: 9 months for each patient	—

Measure

Time frame

Secondary end point(s): The Secondary Outcome Measures are: - For the sensitivity analysis, the endpoint will be defined as 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. Patients for whom pain management would be modified from the protocol will be considered failures. Patients with missing data for pain progression will be considered failures. - Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014). - Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5. - Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.;Timepoint(s) of evaluation of this end point: 9 months for each patient

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Countries

France

Contacts

Public ContactCoordinating Investigator

INSTITUT CLAUDIUS REGAUD

boden.antoine@iuct-oncopole.fr+33531155445

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026