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 Clinical Trial

— IPAC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520701
• Other study ID #: IPAC
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Est. completion date: October 2022

Study information

• Verified date: July 2023
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• bandage skin Hydrotac®
Patients randomized to the arm with bandage skin will benefit from the application of the bandage skin hydrogel (Hydrotac®) at least 5 hours per day for the duration of treatment (the first day last day of radiotherapy).

Drug:
• Ialuset®
Patients randomized to receive reference of the application of cervical Ialuset® on skin throughout the treatment period (the first day to last day of radiotherapy).

Locations

Country	Name	City	State
France	Centre de la Baie	Avranches
France	Centre François BACLESSE	Caen	Calvados
France	Centre Maurice TUBIANA	Caen	Calvados
France	CHU	Caen	Calvados
France	Clinique Leonard de Vinci	Chambray les TOURS
France	centre hospitalier du Cotentin	Cherbourg
France	Centre Guillaume Le Conquérant	Le Havre

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of applying a bandage hydrogel skin on head and neck pains	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).	end of radiotherapy
Secondary	Evaluating the terms of issue of the treatment	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.	during radiotherapy weekly : 1 up to 7 weeks and at 1,3,6,12,18,24,30 and 36 months after radiotherapy