[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621681":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CPAP-addition","EXPERIMENTAL","CPAP is added to standard of care",[13],"Device: Continuous Positive Airway Pressure (CPAP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","NO_INTERVENTION","Right sided or 70 years or older: Free Breathing Left sided and younger than 70 years old: Deep Inspiration Breath Hold",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Continuous Positive Airway Pressure (CPAP)","Positive airway pressure (15cmH2O) delivered by a CPAP-device",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Aline Van der Vorst, MD","CONTACT","+3216340115","aline.vandervorst@uzleuven.be",[32],{"facility":33,"status":34,"city":35,"state":18,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"UZ Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":40,"coordinates":41},"Point",[42,43],4.70093,50.87959,{"lat":43,"lon":42},[46,47,49],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"name":18,"role":28,"phone":18,"phoneExt":18,"email":48},"caroline.weltens@uzleuven.be",{"name":50,"role":51,"phone":18,"phoneExt":18,"email":18},"Caroline Weltens, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[55],{"name":56,"class":57},"VitalAire","INDUSTRY","100621681","phase-2-continuous-positive-airway-pressure-cpap-assisted-radiotherapy-in-breast-cancer-100621681",false,"NCT07373782","Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer","Reducing Cardiac Radiation Dose in Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer: a Prospective Non-Randomized Clinical Trial","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. At least 40 years of age and 80 years or younger at the time of signing the Informed Consent Form (ICF)\n3. Female patients\n4. Patients that underwent breast conserving surgery (BCS)\n5. Left-sided invasive BC \u002F in situ carcinoma with indication for adjuvant RT (\\\u003C70 years old)\n6. Left-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes) (70-80 years old)\n7. Right-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes)\n8. Prior chemotherapy allowed\n9. Prior immunotherapy allowed\n10. Prior \u002F concomitant hormonal therapy allowed\n11. Prior \u002F concomitant HER2-targeted therapy allowed\n\nExclusion Criteria:\n\n1. Patient has active bullous lung disease, bypassed upper airway, pneumothorax, cerebral spinal fluid leaks, abnormalities of the cribriform plate (contra-indications for the use of CPAP)\n2. Patient has history of major head trauma and\u002For pneumocephalus (contra-indications for the use of CPAP)\n3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.\n4. Female who is pregnant, breast-feeding or intends to become pregnant (which is a contra-indication for RT in general)\n5. Male BC patients\n6. Patients that underwent mastectomy Patients whose initial tumor was located just beneath the skin (defined as being less than 28mm below the breast surface), indicating the need for an electron boost\n7. Patients requiring RT boost on positive lymph nodes\n8. Distant metastasis\n9. Breast implants in situ\n10. Right-sided in situ carcinoma\n11. Right-sided invasive BC only requiring local adjuvant RT (without irradiation of the regional lymph nodes, because the presumed benefit on cardiac doses of local right-sided breast irradiation is assumed to be rather small because of the left anatomical position of the heart)\n12. Bilateral BC\n13. Concomitant use of chemotherapy during RT\n14. Substantial comorbidities, incompatible with RT or CPAP use, estimated by the treating radiation oncologist\n15. Insufficient arm mobility to perform comfortable arm positioning in radiation treatment position, evaluated by the treating radiation oncologist\n16. Other active oncological disease \u002F treatment with the exception of non-melanoma skin cancer\n17. Previous RT with overlapping RT fields with actual target volume","FEMALE","40 Years","80 Years",{"count":69,"type":70},53,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE2","PHASE3","This study is a prospective, non-randomized clinical study aimed at investigating the potential benefits of continuous positive airway pressure (CPAP) support during radiotherapy for breast cancer. CPAP is a device commonly used to support breathing, for example in patients with sleep apnea. The investigators expect a reduction in radiation doses to the heart and\u002For lungs with CPAP-supported radiotherapy compared to standard radiotherapy (without CPAP), which may also lead to a decrease in radiation-induced heart and\u002For lung conditions in the long term. The study will also examine how the use of a CPAP device can be implemented in daily radiotherapy practice.",[77],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[79,80,81,82,83,84],"breast cancer","radiotherapy","cpap","continuous positive airway pressure","dosimetry","toxicity","2026-01-22",{"date":87,"type":88},"2026-01-28","ACTUAL",{"date":90,"type":88},"2025-02-11",{"date":92,"type":70},"2027-06",{"name":5,"class":6},1]