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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Francois Baclesse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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