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)

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Ialuset®; Device: bandage skin Hydrotac®

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Avranches, France
    • Centre de la Baie
  • Chambray les TOURS, France, 37000
    • Clinique Léonard de Vinci
  • Cherbourg, France
    • Centre Hospitalier du Cotentin
  • Le Havre, France, 76000
    • Centre Guillaume Le Conquerant
  • Calvados
    • Caen, Calvados, France, 14076
      • Centre François Baclesse
    • Caen, Calvados, France, 14000
      • Centre Maurice Tubiana
    • Caen, Calvados, France, 14033
      • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ialuset® application; Arm with application to the skin Ialuset ® cervical during 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).
Experimental: bandage skin Hydrosorb; Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: David BLANCHARD, MD, Centre François Baclesse; Principal Investigator: Audrey LASNE-CARDON, MD, Centre François Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimated): January 30, 2012

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: radiotherapy; head and neck cancer; radiodermatitis; Hydrotac®; algia
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: IPAC