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 (IPAC)

Centre Francois Baclesse

Status and phase

Completed

Phase 3

Conditions

Head and Neck Cancer

Treatments

Device: bandage skin Hydrotac®

Drug: Ialuset®

Study type

Interventional

Funder types

Other

Identifiers

NCT01520701

IPAC

Details and patient eligibility

About

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.

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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