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)

August 31, 2026 updated by: Centre Francois Baclesse
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avranches, France
        • Centre de la Baie
      • Chambray-lès-Tours, France, 37000
        • Clinique Leonard de Vinci
      • Cherbourg, France
        • centre hospitalier du Cotentin
      • Le Havre, France, 76000
        • Centre Guillaume Le Conquérant
    • CALVADOS
      • Caen, CALVADOS, France, 14076
        • Centre François Baclesse
    • Calvados
      • Caen, Calvados, France, 14000
        • Centre Maurice TUBIANA
      • Caen, Calvados, France, 14033
        • CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: end of radiotherapy (2 months after inclusion)
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 (2 months after inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy Dose Reduction
Time Frame: during 36 months after radiotherapy
Evaluating the terms of issue of the treatment (dose reduction of chemothrapy treatment)
during 36 months after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPAC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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