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

Phase 3

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Ialuset®; Device: bandage skin Hydrotac®

• Registration Number: NCT01520701
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-30
• Study Start: 2012-02
• Primary Completion: 2022-10
• Study Completion: 2022-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ialuset® application	Ialuset®	Arm with application to the skin Ialuset ® cervical during radiotherapy
bandage skin Hydrosorb	bandage skin Hydrotac®	Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy

Primary Outcome Measures

Name	Time	Method
Impact of applying a bandage hydrogel skin on head and neck pains	end of radiotherapy	Assessing the impact of applying a bandage hydrogel skin on head and neck pains in patients with cancer of head and neck treated with concomitant radiotherapy by evaluating the proportion of patients with a deterioration in three or more points to their score algia EVA rating scale at the end of treatment compared to that obtained at baseline (D0).

Secondary Outcome Measures

Name	Time	Method
Evaluating the terms of issue of the treatment	during radiotherapy weekly : 1 up to 7 weeks and at 1,3,6,12,18,24,30 and 36 months after radiotherapy	Evaluating the terms of issue of the treatment (number of interruptions, longer duration of treatment, dose reduction therapeutic influence of psychosocial factors) and quality of life for patients.

Trial Locations

Locations (7)

Centre Maurice TUBIANA; 🇫🇷 Caen, Calvados, France

Centre François BACLESSE; 🇫🇷 Caen, Calvados, France

Clinique Leonard de Vinci; 🇫🇷 Chambray les TOURS, France

CHU; 🇫🇷 Caen, Calvados, France

Centre Guillaume Le Conquérant; 🇫🇷 Le Havre, France

Centre de la Baie; 🇫🇷 Avranches, France

centre hospitalier du Cotentin; 🇫🇷 Cherbourg, France