[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523580":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":27,"locations":38,"responsibleParty":106,"collaborators":108,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":26,"enrollmentInfo":125,"targetDuration":26,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":137,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"University Hospital Schleswig-Holstein","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cannabisextrakt Avextra 10\u002F10 Lösung","EXPERIMENTAL","Solution with tetrahydrocannabinol and cannabidiol",[13],"Drug: Cannabisextrakt Avextra 10\u002F10 Lösung",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Sesame oil, Ph.Eur. Linseed oil, Ph.Eur",[13],[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","medical cannabinoids",[9,15],[25],"Cannabisextrakt Avextra 10\u002F10 solution",null,[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Justus Domschikowski, M.D.","CONTACT","0431500","26511","Justus.Domschikowski@uksh.de",{"name":35,"role":30,"phone":31,"phoneExt":36,"email":37},"Thomas Herdegen, Prof.","30402","Thomas.Herdegen@uksh.de",[39,62,77,90],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)","RECRUITING","Hamburg","Free and Hanseatic City of Hamburg","20246","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],9.99302,53.55073,{"lat":51,"lon":50},[54,59],{"name":55,"role":30,"phone":56,"phoneExt":57,"email":58},"Matthias Rostock, M.D.","+4940 7410","52490","m.rostock@uke.de",{"name":60,"role":30,"phone":26,"phoneExt":26,"email":61},"Marianne Sinn, M.D.","ma.sinn@uke.de",{"facility":5,"status":41,"city":63,"state":64,"zip":65,"country":45,"countryCode":46,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Kiel","Schleswig-Holstein","24105",{"type":48,"coordinates":67},[68,69],10.13489,54.32133,{"lat":69,"lon":68},[72,74],{"name":29,"role":30,"phone":73,"phoneExt":32,"email":33},"0431 500",{"name":75,"role":30,"phone":26,"phoneExt":26,"email":76},"Claudia Schmalz, M.D.","Claudia.Schmalz@uksh.de",{"facility":5,"status":41,"city":63,"state":64,"zip":65,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},{"type":48,"coordinates":79},[68,69],{"lat":69,"lon":68},[82,86],{"name":83,"role":30,"phone":31,"phoneExt":84,"email":85},"Anne Letsch, Prof.","22510","Anne.Letsch@uksh.de",{"name":87,"role":30,"phone":31,"phoneExt":88,"email":89},"Bjoern N Heydrich, M.D.","22513","Bjoern.Heydrich@uksh.de",{"facility":5,"status":41,"city":91,"state":64,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Lübeck",{"type":48,"coordinates":93},[94,95],10.68729,53.86893,{"lat":95,"lon":94},[98,103],{"name":99,"role":30,"phone":100,"phoneExt":101,"email":102},"Franziska Hamm, M.D.","0451 500","44195","AnnaFranziska.Hamm@uksh.de",{"name":104,"role":30,"phone":26,"phoneExt":26,"email":105},"Kim Luley, M.D.","Kim.Luley@uksh.de",{"type":107,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[109,112],{"name":110,"class":111},"Avextra Pharma GmbH","UNKNOWN",{"name":113,"class":114},"SocraMetrics GmbH","INDUSTRY","100523580","phase-2-improvement-of-quality-of-life-by-cannabinoids-in-oncologic-patients-100523580",false,"NCT06097533","Improvement of Quality of Life by Cannabinoids in Oncologic Patients","Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten)","BELCANTO","Inclusion Criteria:\n\n* ≥25 years old and legally competent\n* Palliative oncological therapy\n* ECOG status 1, 2 or 3, incapacitated for work\n* ESAS TSDS \\> or equals 16\n* Nutritional Risk Screening \\> or equals 3\n* Pain numerical rating scale \\> or equals 4\n* informed consent\n* for WOCBP:\n\n  * Negative pregnancy test\n  * Reliable contraception (Pearl Index \\\u003C 1%)\n\nExclusion Criteria:\n\n* nausea \\> or equals grade 3 (CTCAE) or vomiting \\> or equals grade 2 (CTCAE) in the preceding week\n* Inability to understand and complete the questionnaires\n* Cannabis use in the last 6 weeks\n* Alcohol addiction\n* Pregnancy\u002Flactation\n* Contraindications or intolerance to the study medication (esp. psychosis)\n* Simultaneous participation in other clinical studies (sumulataneous participation in non-interventional studies (i.e. biomarker-studies, registries) is allowed, if the study-aim does not interfere with measures of the second study)\n* Any other condition as judged by the investigator, e.g. non-compliance","ALL","25 Years",{"count":126,"type":127},170,"ESTIMATED","INTERVENTIONAL",[130],"PHASE2","The goal is to explore whether the application of cannabis extract Avextra 10\u002F10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.",[133,134,135,136],"Medical Oncology","Palliative Care","Quality of Life","Cannabinoids",[121],"2024-10-23",{"date":140,"type":141},"2024-10-26","ACTUAL",{"date":143,"type":141},"2024-04-08",{"date":145,"type":127},"2026-11-30",{"name":5,"class":6},4]