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
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
head and neck cancer, Hydrotac®, radiodermatitis, algia, radiotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: bandage skin Hydrotac® Type: Device
Name: Ialuset® Type: Drug
Overall Status
Recruiting
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.
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
Locations
Centre François BACLESSE
Caen, Calvados, France
Status: Recruiting
Contact: David BLANCHARD, MD - 02 31 45 50 02 - d.blanchard@baclesse.fr
Centre Maurice TUBIANA
Caen, Calvados, France
Status: Not yet recruiting
Contact: Séverine GUARNIERI, MD
CHU
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
Sponsors
Centre Francois Baclesse
Source
Centre Francois Baclesse
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page