[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369754":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":66,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Hospital Heidelberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tampon with extended vaginal dilatation","EXPERIMENTAL","Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy",[13],"Device: special tampon with a diameter of 28mm",{"label":15,"type":16,"description":17,"interventionNames":18},"Commercially available tampon","ACTIVE_COMPARATOR","Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy",[19],"Device: standard tampon with a diameter of 12-13mm",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","special tampon with a diameter of 28mm","patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"standard tampon with a diameter of 12-13mm","patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy",[15],[32],{"name":33,"affiliation":5,"role":34},"Nathalie Arians, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+49 6221 568202","nathalie.arians@med.uni-heidleberg.de",{"name":41,"role":37,"phone":38,"phoneExt":26,"email":42},"Matthias Haefner, MD","matthias.heafner@med.uni-heidelberg.de",[44],{"facility":45,"status":46,"city":47,"state":26,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Hospital of Heidelberg, Radiation Oncology","RECRUITING","Heidelberg","69120","Germany","DE",{"type":52,"coordinates":53},"Point",[54,55],8.69079,49.40768,{"lat":55,"lon":54},[58,63],{"name":59,"role":37,"phone":60,"phoneExt":61,"email":62},"Jürgen Debus, Prof. Dr.","+49-6221-56","8202","juergen.debus@med.uni-heidelberg.de",{"name":64,"role":37,"phone":60,"phoneExt":61,"email":65},"Adriane Hommertgen","adriane.hommertgen@med.uni-heidelberg.de",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Juergen Debus","Principal Ivestigator","100369754","intrafractional-vaginal-dilation-in-anal-cancer-patients-undergoing-pelvic-radiotherapy-100369754",false,"NCT04094454","Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy","Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study","DILANA","Inclusion Criteria:\n\n* Female patient\n* Histologically confirmed squamous anal cancer\n* Indication for definitive or postoperative radiotherapy\n* ECOG 0-2\n* Age \\> 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* patients refusal or incapability of informed consent\n* no vaginal dilatation possible prior to radiation treatment start\n* prior pelvic irradiation (if direct field border or even overlap of radiation fields assumed)\n* participation in another clinical trial which might influence the results of the DILANA trial\n* pregnancy\u002Fnursing period or inadequate contraception in women with child bearing potential","FEMALE","18 Years",{"count":81,"type":82},60,"ESTIMATED","INTERVENTIONAL",[85],"NA","A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of \\\u003C20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of \\>35-49% as Grade 3 and a reduction \\>\u002F=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.",[88],"Anal Cancer",[90,91,92,93],"female patients","quality of life","vaginal dilator","vaginal fibrosis","2026-03-06",{"date":96,"type":97},"2026-03-10","ACTUAL",{"date":99,"type":97},"2019-10-01",{"date":101,"type":82},"2027-04",{"name":68,"class":6},1]