[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100172609":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":26,"locations":39,"responsibleParty":99,"collaborators":101,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":26,"enrollmentInfo":114,"targetDuration":26,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":129,"whyStopped":26,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Centre Francois Baclesse","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ialuset® application","ACTIVE_COMPARATOR","Arm with application to the skin Ialuset ® cervical during radiotherapy",[13],"Drug: Ialuset®",{"label":15,"type":16,"description":17,"interventionNames":18},"bandage skin Hydrosorb","EXPERIMENTAL","Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy",[19],"Device: bandage skin Hydrotac®",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","bandage skin Hydrotac®","Patients randomized to the arm with bandage skin will benefit from the application of the bandage skin hydrogel (Hydrotac®) at least 5 hours per day for the duration of treatment (the first day last day of radiotherapy).",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Ialuset®","Patients randomized to receive reference of the application of cervical Ialuset® on skin throughout the treatment period (the first day to last day of radiotherapy).",[9],[33,37],{"name":34,"affiliation":35,"role":36},"David BLANCHARD, MD","Centre François Baclesse","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":35,"role":36},"Audrey LASNE-CARDON, MD",[40,53,59,65,73,82,90],{"facility":41,"status":26,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":26},"Centre Maurice TUBIANA","Caen","Calvados","14000","France","FR",{"type":48,"coordinates":49},"Point",[50,51],-0.35912,49.18585,{"lat":51,"lon":50},{"facility":54,"status":26,"city":42,"state":43,"zip":55,"country":45,"countryCode":46,"cosmosGeoPoint":56,"geoPoint":58,"contacts":26},"CHU","14033",{"type":48,"coordinates":57},[50,51],{"lat":51,"lon":50},{"facility":60,"status":26,"city":42,"state":43,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":64,"contacts":26},"Centre François BACLESSE","14076",{"type":48,"coordinates":63},[50,51],{"lat":51,"lon":50},{"facility":66,"status":26,"city":67,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":68,"geoPoint":72,"contacts":26},"Centre de la Baie","Avranches",{"type":48,"coordinates":69},[70,71],-1.35686,48.68436,{"lat":71,"lon":70},{"facility":74,"status":26,"city":75,"state":26,"zip":76,"country":45,"countryCode":46,"cosmosGeoPoint":77,"geoPoint":81,"contacts":26},"Clinique Leonard de Vinci","Chambray-lès-Tours","37000",{"type":48,"coordinates":78},[79,80],0.70286,47.33537,{"lat":80,"lon":79},{"facility":83,"status":26,"city":84,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":85,"geoPoint":89,"contacts":26},"centre hospitalier du Cotentin","Cherbourg",{"type":48,"coordinates":86},[87,88],-1.61636,49.63984,{"lat":88,"lon":87},{"facility":91,"status":26,"city":92,"state":26,"zip":93,"country":45,"countryCode":46,"cosmosGeoPoint":94,"geoPoint":98,"contacts":26},"Centre Guillaume Le Conquérant","Le Havre","76000",{"type":48,"coordinates":95},[96,97],0.10785,49.49346,{"lat":97,"lon":96},{"type":100,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[102],{"name":103,"class":104},"Ministry of Health, France","OTHER_GOV","100172609","phase-3-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-100172609",false,"NCT01520701","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","IPAC","Inclusion Criteria:\n\n* Patient aged 18 years old\n* Carcinoma oral cavity, pharyngolaryngeal or without lymphadenopathy door\n* Patient treated by one of the following diagrams\n\n  * radiotherapy alone\n  * postoperative radiotherapy + \u002F - sensitized platinum (cisplatin or carboplatin)\n  * ar chemoradiation 5-FU and platinum (the Cetuximab is not allowed)\n  * diagram organ preservation (induction chemotherapy and radiotherapy in responders)\n* Untreated patients\n* Patient should receive conventional radiotherapy or tomotherapy\n* Adapted stomatological care\n* Life expectancy \\> 3 months\n* WHO score \\\u003C 2\n* Patient stable, not having the time of the examination of evidence of recurrent or progressive malignancy other\n* \\- For patients with an indication of chemotherapy combined with radiotherapy,biological assessments compatible with chemotherapy:\n\n  * WBC \\> 3000\u002Fmm3, Polynuclear \\> 2000\u002Fmm3,Platelets \\> 150,000\u002Fmm3, Creatinine less than 2 times normal; Bilirubin less than 2.5 times normal\n* Patient fluent in French\n* Affiliation to a system of social security\n* Patient has given written consent\n\nExclusion Criteria:\n\n* Patient with a history of malignancy, outside a basal cell carcinoma or cervical cancer treated and cured\n* Patient has at the time of examination signs of recurrence or other neoplasia scalable\n* Patient with a history of prior chemotherapy or radiation therapy with the exception of the scheme of organ preservation (induction chemotherapy before radiation)\n* For patients with an indication of chemotherapy combined with radiotherapy, contraindication to treatment with specific platinum (cisplatin or carboplatin) with or without 5 Fluorouracil\n* Infectious diseases uncontrolled\n* Patient is pregnant or lactating or absence of contraception during their reproductive\n* Patient hypertensive unbalanced under antihypertensive treatment\n* Uncontrolled cardiac disease\n* Patients with renal or hepatic\n* Known allergy to any component of Ialuset ®\n* Patient deprived of liberty under guardianship\n* Any medical condition or psychological associate that could compromise the patient's ability to participate in the study\n* Inability to undergo medical test for geographical, social or psychological","ALL","18 Years",{"count":115,"type":116},125,"ESTIMATED","INTERVENTIONAL",[119],"PHASE3","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.",[122],"Head and Neck Cancer",[124,125,126,127,128],"head and neck cancer","Hydrotac®","radiodermatitis","algia","radiotherapy","COMPLETED","2023-07-26",{"date":132,"type":133},"2023-07-27","ACTUAL",{"date":135,"type":133},"2012-02",{"date":137,"type":133},"2022-10",{"name":5,"class":6},7]