Status:
COMPLETED
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
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01520701
Start Date
February 1 2012
End Date
October 1 2022
Last Update
July 27 2023
Active Locations (7)
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1
Centre Maurice TUBIANA
Caen, Calvados, France, 14000
2
CHU
Caen, Calvados, France, 14033
3
Centre François BACLESSE
Caen, Calvados, France, 14076
4
Centre de la Baie
Avranches, France