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
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
head and neck cancer, Hydrotac®, radiodermatitis, algia, radiotherapy
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Name: bandage skin Hydrotac® Type: Device
Name: Ialuset® Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Centre François BACLESSE
Caen, Calvados, France
Status: Recruiting
Contact: David BLANCHARD, MD - 02 31 45 50 02 -
Centre Maurice TUBIANA
Caen, Calvados, France
Status: Not yet recruiting
Contact: Séverine GUARNIERI, MD
Caen, Calvados, France
Status: Recruiting
Contact: Emmanuel BABIN, PD
Clinique Leonard de Vinci
Chambray les TOURS, France
Status: Recruiting
Contact: Thomas BOISSERIE, MD
Start Date
February 2012
Completion Date
September 2019
Centre Francois Baclesse
Centre Francois Baclesse
Record processing date processed this data on July 28, 2015 page