A gel bandage may soothe radiation burns in head and neck cancer

NCT ID NCT01520701

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether wearing a hydrogel bandage on the skin of the head and neck during radiation therapy can reduce pain and skin irritation in people with head and neck cancer. About 130 participants will either wear the bandage for at least 5 hours a day during treatment or use a standard skin cream. Researchers will compare pain scores and quality of life between the two groups to see if the bandage offers better relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A hydrogel bandage (Hydrotac®) applied to the skin of the head and neck during radiotherapy, compared with a standard skin cream (Ialuset®).
What this could lead to
If it works, this could offer a simple, non-drug way to ease pain and skin irritation during radiotherapy, improving quality of life for people with head and neck cancer.
What could go wrong
The trial is still testing the idea, and the bandage may not reduce pain more than the standard cream. Some people may find the bandage uncomfortable or develop skin reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

130 people

The number who actually took part.

Started

Feb 2012

Finished

Oct 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU

    Caen, Calvados, 14033, France

  • Centre François BACLESSE

    Caen, CALVADOS, 14076, France

  • Centre Guillaume Le Conquérant

    Le Havre, 76000, France

  • Centre Maurice TUBIANA

    Caen, Calvados, 14000, France

  • Centre de la Baie

    Avranches, France

  • Clinique Leonard de Vinci

    Chambray-lès-Tours, 37000, France

  • centre hospitalier du Cotentin

    Cherbourg, France

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