Head and Neck Cancer Clinical Trial
— IPACOfficial 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
NCT number | NCT01520701 |
Other study ID # | IPAC |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | February 2012 |
Est. completion date | October 2022 |
Verified date | July 2023 |
Source | Centre Francois Baclesse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 125 |
Est. completion date | October 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre de la Baie | Avranches | |
France | Centre François BACLESSE | Caen | Calvados |
France | Centre Maurice TUBIANA | Caen | Calvados |
France | CHU | Caen | Calvados |
France | Clinique Leonard de Vinci | Chambray les TOURS | |
France | centre hospitalier du Cotentin | Cherbourg | |
France | Centre Guillaume Le Conquérant | Le Havre |
Lead Sponsor | Collaborator |
---|---|
Centre Francois Baclesse | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | end of radiotherapy | |
Secondary | Evaluating the terms of issue of the treatment | Evaluating the terms of issue of the treatment (number of interruptions, longer duration of treatment, dose reduction therapeutic influence of psychosocial factors) and quality of life for patients. | during radiotherapy weekly : 1 up to 7 weeks and at 1,3,6,12,18,24,30 and 36 months after radiotherapy |
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