Clinical trial NCT01520701: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
Hydrotac®
radiodermatitis
algia
radiotherapy
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2012-01-30
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Impact of applying a bandage hydrogel skin on head and neck pains
timeFrame: end of radiotherapy
Secondary outcomes:
measure: Evaluating the terms of issue of the treatment
timeFrame: during radiotherapy weekly : 1 up to 7 weeks and at 1,3,6,12,18,24,30 and 36 months after radiotherapy
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Maurice TUBIANA
state: Calvados
city: Caen
country: France
facility: CHU
state: Calvados
city: Caen
country: France
facility: Centre François BACLESSE
state: Calvados
city: Avranches
country: France
facility: Centre de la Baie
city: Chambray les TOURS
country: France
facility: Clinique Leonard de Vinci
city: Cherbourg
country: France
facility: centre hospitalier du Cotentin
city: Le Havre
country: France
facility: Centre Guillaume Le Conquérant
Study officials:
affiliation: Centre François Baclesse
name: David BLANCHARD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre François Baclesse
name: Audrey LASNE-CARDON, MD
role: PRINCIPAL_INVESTIGATOR
References: