[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466786":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":26,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"AHS Cancer Control Alberta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention using the Airvo device","EXPERIMENTAL","Patients randomized to this group will receive the standard of care as well as wear the Airvo (equipment to provide high heated humidity) starting on Day 0 of their transplant for a minimum of 4 hours a day (to be worn in one continuous block of time). The humidity is delivered by nasal cannula that goes into your nose, similar to wearing oxygen. The equipment stands on a pole and plugs into a power outlet. Patients may take off the equipment for short periods of time. Eg to go to the bathroom.",[13],"Device: Airvo",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR","Patients randomized into this group will receive the usual standard of care for mucositis.\n\nThe standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.",[19],"Other: Standard of Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Airvo","Fisher \\& Paykel's AIRVO 2 is a humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of interfaces including nasal cannula. Flow can be delivered from 2 to 60 LPM",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.",[15],[31],{"name":32,"affiliation":33,"role":34},"Lisa Lem","Cross Cancer Institute, Alberta Health Services","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","780-432-8580","Lisa.Lem@albertahealthservices.ca",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Cross Cancer Institute","RECRUITING","Edmonton","Alberta","T6G 1Z2","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-113.46871,53.55014,{"lat":53,"lon":52},[56],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100466786","phase-2-high-heated-humidity-in-stem-cell-transplant-100466786",false,"NCT05358262","High Heated Humidity in Stem Cell Transplant","Using Highly Heated Humidification to Minimize Aerodigestive Tract Complications of Autologous Stem Cell Transplant","Inclusion Criteria:\n\n1. Minimum 18 years of age\n2. Have given written consent prior to any study-specific procedures or have had an acceptable individual capable of giving consent on the patient's behalf.\n3. Have one of non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma and found to require high-dose, melphalan-based chemotherapy and autologous stem cell transplant (ASCT) as part of standard of care treatment (includes patients receiving ASCT also requiring oxygen).\n4. Performance status of ECOG 0-2\n5. Are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.\n\nExclusion Criteria:\n\n1. Nasal blockage such as nasal polyps, deviated septum or nasal packing would either not allow the proper flow of heated humidity into the nares or it would be too uncomfortable to tolerate during the intervention.\n2. Those with influenza like illness. The intervention is not in itself, an aerosol generating medical device. However, if influenza positive, there could be airborne spread of the virus impacting both staff and other patients.\n3. Tracheostomy Tube Patients would require a different type of equipment attachment which is not included in this study. Tracheostomy tubes by-pass the upper airway and therefore the intervention cannot be used for the purpose of assessing mucositis. This intervention is used regularly on tracheostomy patients with good success however in this case, the upper airway is by-passed and therefore there would be no impact on mucositis.\n4. Patients with significant co-morbidities that would prevent compliance of equipment use as determined by the treating physician.\n5. Patients who have Obstructive Sleep Apnea who use a CPAP machine at night. This population would not be able to use the intervention concurrently with the CPAP device as both utilize the nares.","ALL","18 Years",{"count":69,"type":70},90,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis.",[76],"Autologous Stem Cell Transplant",[78],"Mucositis","2025-01-28",{"date":81,"type":82},"2025-01-30","ACTUAL",{"date":84,"type":82},"2024-11-05",{"date":86,"type":70},"2026-01",{"name":5,"class":6},1]