Head and Neck CancerPhase 2TEC-ORLNCT04704453
Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.
A Phase 2 study testing Capsaïcin patch (Qutenza®) and Amitriptyline (Laroxyl®) in people with Head and Neck Cancer, run by Institut Claudius Regaud at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Capsaïcin patch (Qutenza®) and Amitriptyline (Laroxyl®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesFrance
- Study dates
- 28 Apr 2021to 28 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Patient affiliated to a Social Health Insurance in France.
- Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
Who cannot join
- 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.
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- Contraindication to amitriptyline treatment.
- Patient with an unhealed skin lesion on the area to be treated.
- Previous treatment with capsaicin or amitriptyline.
- Topical treatment of the painful area used for more than 21 days before inclusion.
- 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).
Trial locations and contacts
4 sites in 1 country.
France4 sites
INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers
Angers
Institut Sainte-Catherine
Avignon
Hôpital Saint-Joseph
Marseille, 13285
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31059
About this study
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.
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
- Being tested
- Capsaïcin patch (Qutenza®), Amitriptyline (Laroxyl®)
- Keywords
- Neuropathic Pain, Capsaicin patch, Amitriptyline
- Medical subject headings
- Head and Neck Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaïcin patch (Qutenza®)Drug
Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).
Amitriptyline (Laroxyl®)Drug
Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm (A): capsaicin patch | Experimental | Not described Receives: Drug: Capsaïcin patch (Qutenza®) |
| Standard arm (B): amitriptyline | Other | Not described Receives: Drug: Amitriptyline (Laroxyl®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months for each patient
Secondary outcomes (3)
Neuropathic pain according to the Neuropathic Pain Symptom Inventory (NPSI) questionnaire.
Measured: 9 months for each patient
Adverse events of the drugs evaluated using the NCI-CTC AE V5.
Measured: 9 months for each patient
Quality of life evaluated according to the Quality of Life Questionnaire-Core 30 (QLQ-C30).
Measured: 9 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start28 Apr 2021
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704453
- Sponsor's protocol ID
- 20 VADS 04
- Acronym
- TEC-ORL
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2021
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36471253
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04704453
- Acronym / sponsor ID
- TEC-ORL / 20 VADS 04
- Conditions
- Head and Neck Cancer
- Keywords
- Neuropathic Pain, Capsaicin patch, Amitriptyline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm (A): capsaicin patch | Experimental | Drug: Capsaïcin patch (Qutenza®) |
| Standard arm (B): amitriptyline | Other | Drug: Amitriptyline (Laroxyl®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaïcin patch (Qutenza®)Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7). | Drug | Experimental arm (A): capsaicin patch |
| Amitriptyline (Laroxyl®)Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily. | Drug | Standard arm (B): amitriptyline |
Primary outcome
The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
Time frame: 9 months for each patient
Pain will be assessed using a numerical scale from 0 to 10.
3 secondary outcomes
Neuropathic pain according to the Neuropathic Pain Symptom Inventory (NPSI) questionnaire.
Time frame: 9 months for each patient
Adverse events of the drugs evaluated using the NCI-CTC AE V5.
Time frame: 9 months for each patient
Quality of life evaluated according to the Quality of Life Questionnaire-Core 30 (QLQ-C30).
Time frame: 9 months for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 36471253Boden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capsaïcin patch (Qutenza®) and Amitriptyline (Laroxyl®) in people with Head and Neck Cancer, run by Institut Claudius Regaud at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion. (time frame: 9 months for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.