Head and Neck CancerPhase 3IPACNCT01520701
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
A Phase 3 study testing bandage skin Hydrotac® and Ialuset® in people with Head and Neck Cancer, run by Centre Francois Baclesse at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- bandage skin Hydrotac® and Ialuset®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 7 sitesFrance
- Study dates
- Feb 2012to Oct 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre de la Baie
Avranches
Centre Maurice TUBIANA
Caen, Calvados, 14000
CHU
Caen, Calvados, 14033
Centre François BACLESSE
Caen, CALVADOS, 14076
Clinique Leonard de Vinci
Chambray-lès-Tours, 37000
centre hospitalier du Cotentin
Cherbourg
Centre Guillaume Le Conquérant
Le Havre, 76000
About this study
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.
- Conditions
- Head and Neck Cancer
- Being tested
- bandage skin Hydrotac®, Ialuset®
- Keywords
- head and neck cancer, Hydrotac®, radiodermatitis, algia, radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bandage skin Hydrotac®Device
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).
Ialuset®Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Ialuset® application | Active comparator | Arm with application to the skin Ialuset ® cervical during radiotherapy Receives: Drug: Ialuset® |
| bandage skin Hydrosorb | Experimental | Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy Receives: Device: bandage skin Hydrotac® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: end of radiotherapy (2 months after inclusion)
Secondary outcomes (1)
Chemotherapy Dose Reduction
Evaluating the terms of issue of the treatment (dose reduction of chemothrapy treatment)
Measured: during 36 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- David BLANCHARD, MD, Principal investigator, Centre François BaclesseAudrey LASNE-CARDON, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520701
- Sponsor's protocol ID
- IPAC
- Acronym
- IPAC
- Status last verified
- Aug 2026
- First submitted
- 13 Jan 2012
- Last updated
- 1 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01520701
- Acronym / sponsor ID
- IPAC / IPAC
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, Hydrotac®, radiodermatitis, algia, radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Feb 2012 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Posted 1 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ialuset® application | Active comparator | Drug: Ialuset®Arm with application to the skin Ialuset ® cervical during radiotherapy |
| bandage skin Hydrosorb | Experimental | Device: bandage skin Hydrotac®Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient aged 18 years old
- Carcinoma oral cavity, pharyngolaryngeal or without lymphadenopathy door
- Patient treated by one of the following diagrams
- Untreated patients
- Patient should receive conventional radiotherapy or tomotherapy
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | bandage skin Hydrosorb |
| 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). | Drug | Ialuset® application |
Primary outcome
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).
1 secondary outcome
Chemotherapy Dose Reduction
Time frame: during 36 months after radiotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David BLANCHARD, MD principal investigator
Centre François Baclesse
Audrey LASNE-CARDON, MD principal investigator
Centre François Baclesse
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bandage skin Hydrotac® and Ialuset® in people with Head and Neck Cancer, run by Centre Francois Baclesse at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Applying a Bandage Hydrogel Skin on Head and Neck Pains (time frame: end of radiotherapy (2 months after inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.