Clinical trial · Interventional
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
NCT01520701CI-TRIAL-00125106IPACcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bandage skin Hydrotac® | Device | — | UNRESOLVED |
| Ialuset® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ialuset® application
- description
- Arm with application to the skin Ialuset ® cervical during radiotherapy
- interventionNames
- Drug: Ialuset®
- type
- EXPERIMENTAL
- label
- bandage skin Hydrosorb
- description
- Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy
- interventionNames
- Device: bandage skin Hydrotac®
Primary outcomes (1)
- measure
- Impact of Applying a Bandage Hydrogel Skin on Head and Neck Pains
- timeFrame
- end of radiotherapy (2 months after inclusion)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.