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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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The investigators hope to get by reduced and delayed acute radiodermatitis following the application of dressings to skin hydrogel Hydrosorb®, a reduction in head and neck pains and improved quality of life of patients with head and neck cancer treated with concomitant radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ialuset® application | Active Comparator | Arm with application to the skin Ialuset ® cervical during radiotherapy |
|
| bandage skin Hydrosorb | Experimental | Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bandage skin Hydrotac® | Device | Patients randomized to the arm with bandage skin will benefit from the application of the bandage skin hydrogel (Hydrotac®) at least 5 hours per day for the duration of treatment (the first day last day of radiotherapy). |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of applying a bandage hydrogel skin on head and neck pains | Assessing the impact of applying a bandage hydrogel skin on head and neck pains in patients with cancer of head and neck treated with concomitant radiotherapy by evaluating the proportion of patients with a deterioration in three or more points to their score algia EVA rating scale at the end of treatment compared to that obtained at baseline (D0). | end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the terms of issue of the treatment | Evaluating the terms of issue of the treatment (number of interruptions, longer duration of treatment, dose reduction therapeutic influence of psychosocial factors) and quality of life for patients. | during radiotherapy weekly : 1 up to 7 weeks and at 1,3,6,12,18,24,30 and 36 months after radiotherapy |
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Inclusion Criteria:
Patient aged 18 years old
Carcinoma oral cavity, pharyngolaryngeal or without lymphadenopathy door
Patient treated by one of the following diagrams
Untreated patients
Patient should receive conventional radiotherapy or tomotherapy
Adapted stomatological care
Life expectancy > 3 months
WHO score < 2
Patient stable, not having the time of the examination of evidence of recurrent or progressive malignancy other
- For patients with an indication of chemotherapy combined with radiotherapy,biological assessments compatible with chemotherapy:
Patient fluent in French
Affiliation to a system of social security
Patient has given written consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David BLANCHARD, MD | Centre François Baclesse | Principal Investigator |
| Audrey LASNE-CARDON, MD | Centre François Baclesse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Maurice TUBIANA | Caen | Calvados | 14000 | France | ||
| CHU |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 2, 2026 | |
| Reset | Jun 25, 2026 |
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| Ialuset® | Drug | Patients randomized to receive reference of the application of cervical Ialuset® on skin throughout the treatment period (the first day to last day of radiotherapy). |
|
| Caen |
| Calvados |
| 14033 |
| France |
| Centre François BACLESSE | Caen | Calvados | 14076 | France |
| Centre de la Baie | Avranches | France |
| Clinique Leonard de Vinci | Chambray-lès-Tours | 37000 | France |
| centre hospitalier du Cotentin | Cherbourg | France |
| Centre Guillaume Le Conquérant | Le Havre | 76000 | France |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 2, 2026 | Jun 25, 2026 | |||
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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