[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100322725":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":34,"studyPopulation":23,"armGroups":35,"interventions":46,"overallOfficials":52,"centralContacts":56,"locations":61,"responsibleParty":89,"collaborators":91,"id":110,"slug":23,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":23,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":23,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":23,"overallStatus":77,"whyStopped":23,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Göteborg University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":23},[9,13,15,17,19,21],{"measure":10,"description":11,"timeFrame":12},"Oral mucositis","Reduced incidence of clinical mucositis assessed using Oral Mucositis Assessment Scale (9 areas in the mouth are examined and signs of ulceration are scored; 0=no lesion,1= lesion \\\u003C1cm2, 2=lesion 1-3 cm2, 3=lesion \\> 3 cm2 as well as erythema, which is scored as follows: 0=no erythema, 1= mild erythema and 2=severe erythema. Total score for ulceration can vary from 0-27 and for erythema from 0-18. Mucositis is present at scores ≥ 1.)","First week of RT (mucositis score at one time-point)",{"measure":10,"description":11,"timeFrame":14},"Second week of RT (mucositis score at one time-point)",{"measure":10,"description":11,"timeFrame":16},"Third week of RT (mucositis score at one time-point)",{"measure":10,"description":11,"timeFrame":18},"Fourth week of RT (mucositis score at one time-point)",{"measure":10,"description":11,"timeFrame":20},"Fifth week of RT (mucositis score at one time-point)",{"measure":10,"description":11,"timeFrame":22},"Sixth week of RT (mucositis score at one time-point)",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","Intervention group: intensified oral care programme Control group: conventional oral care","PREVENTION",{"masking":30,"maskingDescription":31,"whoMasked":32},"SINGLE","The participants will not be aware of the care\u002Ftreatment given to the other group",[33],"PARTICIPANT","This study will evaluate the effect of an oral care programme on prevalence, severity and duration of mucositis in patients undergoing treatment for cancer in the head and neck region. The oral care programme consists of professional oral care and swabbing of the mucosal membranes with a saline\u002Fbicarbonate solution once a week. The patients are instructed to rinse with a saline\u002Fbicarbonate solution 5 times per day. They are given an oral care diary to help them keep track of their daily oral hygiene measures and rinses. Repeated oral hygiene instructions are given if needed.\n\nPatients in the control group get professional oral care once a week.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Intervention","ACTIVE_COMPARATOR","The intervention consists of professional oral care and swabbing of the mucosal membranes with a saline and bicarbonate solution, five daily rinses with a saline and bicarbonate solution, a diary to register oral care measures and rinses",[41],"Procedure: Oral care programme",{"label":43,"type":44,"description":45,"interventionNames":23},"Control","NO_INTERVENTION","Professional oral care once a week according to existing routine",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":23},"PROCEDURE","Oral care programme","Professional oral care (dental hygienist), intensified oral care measures by the patient",[37],[53],{"name":54,"affiliation":5,"role":55},"Annica Almståhl, Assoc.prof","PRINCIPAL_INVESTIGATOR",[57],{"name":54,"role":58,"phone":59,"phoneExt":23,"email":60},"CONTACT","+46317863208","annica.almstahl@odontologi.gu.se",[62,75],{"facility":63,"status":64,"city":65,"state":23,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":23},"Institute of odontology","ACTIVE_NOT_RECRUITING","Gothenburg","41390","Sweden","SE",{"type":70,"coordinates":71},"Point",[72,73],11.96679,57.70716,{"lat":73,"lon":72},{"facility":76,"status":77,"city":78,"state":23,"zip":23,"country":67,"countryCode":68,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Länssjukhuset Ryhov","RECRUITING","Jönköping",{"type":70,"coordinates":80},[81,82],14.15618,57.78145,{"lat":82,"lon":81},[85],{"name":86,"role":58,"phone":87,"phoneExt":23,"email":88},"Charlott Karlsson, RDH","+4636326000","charlott.karlsson@rjl.se",{"type":90,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[92,94,97,99,101,103,106,108],{"name":93,"class":6},"Ryhov County Hospital",{"name":95,"class":96},"Region Jönköping County","OTHER_GOV",{"name":98,"class":6},"Swedish Cancer Foundation",{"name":100,"class":6},"Kalmar County Hospital",{"name":102,"class":6},"Norrlands University Hospital",{"name":104,"class":105},"The Sjöberg Foundation","UNKNOWN",{"name":107,"class":105},"TUA research funding: The Sahlgrenska Academy\u002FRegion Västra Götaland",{"name":109,"class":6},"Malmö University","100322725",false,"NCT03481647","Evaluation of an Oral Care Programme for Head and Neck Cancer Patients","Evaluation of an Oral Care Programme for Patients Undergoing Treatment for Head and Neck Cancer Regarding Mucositis, Oral Health, Epigenetic Modifications, Patient-related Factors, Quality of Life and Health Economy","Inclusion Criteria:\n\n* Patients scheduled to receive full dose of curative RT including major salivary glands in the radiation field\n\nExclusion Criteria:\n\n* Patients with recurrent cancer\n* Patients with severe cognitive impairment.","ALL","18 Years","80 Years",{"count":120,"type":121},150,"ESTIMATED","INTERVENTIONAL",[124],"NA","This study will evaluate the effect of an intensified oral care programme on prevalence, severity and duration of mucositis in patients undergoing treatment for cancer in the head and neck region.\n\nPatients in the control group get professional oral care once a week.",[127],"Head and Neck Cancer","2025-04-16",{"date":130,"type":131},"2025-04-20","ACTUAL",{"date":133,"type":131},"2018-01-08",{"date":135,"type":121},"2026-12-31",{"name":5,"class":6},2]