[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100196991":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":30,"locations":44,"responsibleParty":94,"collaborators":30,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":27,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":30,"enrollmentInfo":105,"targetDuration":30,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":119,"whyStopped":30,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Organ, Tissue, Regeneration, Repair and Replacement","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","This arm receives a placebo (saline solution) mouthwash treatment twice a day.",[13],"Device: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"MUCIPLIQ 0.05 mg\u002FmL","EXPERIMENTAL","This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg\u002FmL twice a day.",[19],"Device: MUCIPLIQ",{"label":21,"type":16,"description":22,"interventionNames":23},"MUCIPLIQ 0.015 mg\u002FmL","This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg\u002FmL twice a day.",[19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","MUCIPLIQ","MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.",[21,15],null,{"type":26,"name":9,"description":32,"armGroupLabels":33,"otherNames":30},"Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.",[9],[35,39,41],{"name":36,"affiliation":37,"role":38},"Nicolas Daly-Schveitzer, MD, PhD","Institut Gustave Roussy, Villejuif, France","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":37,"role":38},"Yungan Tao, MD",{"name":42,"affiliation":5,"role":43},"Denis BARRITAULT, PhD","STUDY_DIRECTOR",[45,57,66,76,85],{"facility":46,"status":30,"city":47,"state":30,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":30},"Centre de Cancérologie Léon Bérard","Lyon","69373","France","FR",{"type":52,"coordinates":53},"Point",[54,55],4.84789,45.74906,{"lat":55,"lon":54},{"facility":58,"status":30,"city":59,"state":30,"zip":60,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":65,"contacts":30},"CHRU de Besançon, Site du CH Belfort-Montbéliard","Montbéliard","25200",{"type":52,"coordinates":62},[63,64],6.79823,47.50957,{"lat":64,"lon":63},{"facility":67,"status":30,"city":68,"state":69,"zip":70,"country":49,"countryCode":50,"cosmosGeoPoint":71,"geoPoint":75,"contacts":30},"Centre Hospitalier Intercommunal de Créteil","Créteil","Île-de-France Region","94010",{"type":52,"coordinates":72},[73,74],2.46569,48.79266,{"lat":74,"lon":73},{"facility":77,"status":30,"city":78,"state":69,"zip":79,"country":49,"countryCode":50,"cosmosGeoPoint":80,"geoPoint":84,"contacts":30},"APHP - Hôpital Tenon","Paris","75970",{"type":52,"coordinates":81},[82,83],2.3488,48.85341,{"lat":83,"lon":82},{"facility":86,"status":30,"city":87,"state":69,"zip":88,"country":49,"countryCode":50,"cosmosGeoPoint":89,"geoPoint":93,"contacts":30},"Institut de Cancérologie Gustave Roussy","Villejuif","94800",{"type":52,"coordinates":90},[91,92],2.35992,48.7939,{"lat":92,"lon":91},{"type":95,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100196991","efficacy-of-mucipliq-on-the-incidence-of-radio-chemotherapy-induced-mucositis-in-patients-suffering-from-oral-cancer-100196991",false,"NCT01840436","Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer","A Randomized Controlled Study Evaluating the Effect of MUCIPLIQ Versus Placebo on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering of Upper Aerodigestive Tract Carcinomas","Inclusion Criteria:\n\n* Patient suffering from an upper aerodigestive tract carcinoma treated by radiotherapy alone or radiotherapy associated with a concomitant platine-salts-based chemotherapy ;\n* Patient suffering of an upper aerodigestive tract carcinoma without entrance or located in the oral cavity, in the oropharynx or in the rhinopharynx ;\n* Patient age of 18 years old or higher ;\n* Writing informed consent to participate to the trial ;\n* Patient affiliated to the French social security system.\n\nExclusion Criteria:\n\n* Treatment by non-standard fragmentation (concentrate irradiation)\n* Carcinoma located in the hypopharynx or in the larynx ;\n* Known hypersensitivity to heparinoids ;\n* Patient who already benefited from a radiotherapy treatment ;\n* Patient who already benefited from a chemotherapy treatment. Patients who benefited from neoadjuvant chemotherapy as part of their upper aerodigestive tract carcinoma care, may be included if it was held at least 4 weeks before the inclusion visit ;\n* Patient participating to another biomedical research ;\n* Pregnant woman, breastfeeding woman, parturient or likely to be ;\n* Patient deprived of freedom, under supervision or guardianship ;\n* Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons","ALL","18 Years",{"count":106,"type":107},136,"ACTUAL","INTERVENTIONAL",[110],"NA","MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix scaffold and cells communication, a process known as Matrix Therapy.\n\nThe purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of upper aerodigestive tract cancers, when used as a preventive agent.\n\nThe study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.",[113,114],"Oral Mucositis","Carcinoma in Situ of Upper Respiratory Tract",[27,116,117,118],"Matrix therapy","RGTA","Oral mucositis","COMPLETED","2016-05-04",{"date":122,"type":123},"2016-05-05","ESTIMATED",{"date":125,"type":30},"2013-03",{"date":127,"type":107},"2015-01",{"name":5,"class":6},5]