A gel bandage may soothe radiation burns in head and neck cancer
NCT ID NCT01520701
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.
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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
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130 people
The number who actually took part.
- Started
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Feb 2012
- Finished
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Oct 2022
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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CHU
Caen, Calvados, 14033, France
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Centre François BACLESSE
Caen, CALVADOS, 14076, France
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Centre Guillaume Le Conquérant
Le Havre, 76000, France
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Centre Maurice TUBIANA
Caen, Calvados, 14000, France
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Centre de la Baie
Avranches, France
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Clinique Leonard de Vinci
Chambray-lès-Tours, 37000, France
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centre hospitalier du Cotentin
Cherbourg, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A prospective imaging study of target definition and radiation planning workflows on the integrated TrueBeam-HyperSight system for patients receiving radiation therapy
- Can a Self-Care program ease Post-Cancer swelling in the head and neck?
- Blood biomarkers may foreshadow Radiation-Induced dry mouth
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can a smart breathing device make life with a tracheostomy more comfortable?
- A simple dye might replace radioactive tracers in cancer staging