Impact of Applying a Bandage Skin Hydrogel on the Pains of the Head and Neck in Patients With Cancer of Head and Neck Treated With Radiotherapy

• Status: Active, not recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Francois Baclesse
• Collaborator: Ministry of Health, France

Criteria

Inclusion Criteria:

• Patient aged 18 years old

• Carcinoma oral cavity, pharyngolaryngeal or without lymphadenopathy door

• Patient treated by one of the following diagrams

• radiotherapy alone

• postoperative radiotherapy + / - sensitized platinum (cisplatin or carboplatin)

• ar chemoradiation 5-FU and platinum (the Cetuximab is not allowed)

• diagram organ preservation (induction chemotherapy and radiotherapy in responders)

• 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:

• WBC > 3000/mm3, Polynuclear > 2000/mm3,Platelets > 150,000/mm3, Creatinine less than 2 times normal; Bilirubin less than 2.5 times normal

• Patient fluent in French

• Affiliation to a system of social security

• Patient has given written consent

Exclusion Criteria:

• Patient with a history of malignancy, outside a basal cell carcinoma or cervical cancer treated and cured

• Patient has at the time of examination signs of recurrence or other neoplasia scalable

• Patient with a history of prior chemotherapy or radiation therapy with the exception of the scheme of organ preservation (induction chemotherapy before radiation)

• For patients with an indication of chemotherapy combined with radiotherapy, contraindication to treatment with specific platinum (cisplatin or carboplatin) with or without 5 Fluorouracil

• Infectious diseases uncontrolled

• Patient is pregnant or lactating or absence of contraception during their reproductive

• Patient hypertensive unbalanced under antihypertensive treatment

• Uncontrolled cardiac disease

• Patients with renal or hepatic

• Known allergy to any component of Ialuset ®

• Patient deprived of liberty under guardianship

• Any medical condition or psychological associate that could compromise the patient's ability to participate in the study

• Inability to undergo medical test for geographical, social or psychological