[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556854":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":50,"collaborators":53,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Sir Mortimer B. Davis - Jewish General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","The treating physician will perform the injection of normal saline under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of normal saline will be infiltrated the major salivary glands at-risk.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"onabotulinumtoxinA","EXPERIMENTAL","The treating physician will perform the injection of onabotulinumtoxinA under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of onabotulinumtoxinA will be infiltrated the major salivary glands at-risk.",[19],"Drug: OnabotulinumtoxinA",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","OnabotulinumtoxinA","Injection of onabotulinumtoxinA into the at-risk major salivary glands",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"Injection of normal saline into the at-risk major salivary glands",[9],[31],{"facility":32,"status":26,"city":33,"state":34,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"McGill University","Montreal","Quebec","Canada","CA",{"type":38,"coordinates":39},"Point",[40,41],-73.58781,45.50884,{"lat":41,"lon":40},[44,48],{"name":45,"role":46,"phone":26,"phoneExt":26,"email":47},"Marco A Mascarella, MD","CONTACT","marco.mascarella@mcgill.ca",{"name":45,"role":49,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Marco Mascarella","Principal Investigator",[54,56],{"name":55,"class":6},"Lady Davis Institute",{"name":57,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","100556854","phase-2-pretreatment-botulinum-toxin-in-head-and-neck-cancer-surgery-100556854",false,"NCT06530524","Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery","Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer","Inclusion Criteria:\n\n* Newly diagnosis AJCC 8th edition Stage III\u002FIVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).\n\nExclusion Criteria:\n\n* Previous radiation to the head and neck\n* Previous treatment for head and neck cancer\n* Personal history of xerostomia\n* Hypersensitivity to onabotulinumtoxinA\n* Previous major salivary gland surgery\n* Previous exposure to radioactive iodine therapy","ALL","18 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.",[75,76],"Head Neck Cancer","Xerostomia Following Radiotherapy",[78,79,80,81],"Head and Neck Cancer","Radiation induce xerostoma","botulinum toxin","salivary glands","NOT_YET_RECRUITING","2024-07-26",{"date":85,"type":86},"2024-07-31","ACTUAL",{"date":88,"type":69},"2024-10-01",{"date":90,"type":69},"2027-12-01",{"name":5,"class":6},1]