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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm (A): capsaicin patch | Experimental |
| |
| Standard arm (B): amitriptyline | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaïcin patch (Qutenza®) | Drug | Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers | Angers | France | ||||
| Institut Sainte-Catherine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36471253 | Background | 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. |
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| Amitriptyline (Laroxyl®) | Drug | Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily. |
|
| Quality of life evaluated according to the Quality of Life Questionnaire-Core 30 (QLQ-C30). | 9 months for each patient |
| Avignon |
| France |
| HĂ´pital Saint-Joseph | Marseille | 13285 | France |
| Institut Universitaire du Cancer Toulouse - Oncopole | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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