[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415500":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":46,"responsibleParty":76,"collaborators":78,"id":80,"slug":44,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":44,"enrollmentInfo":89,"targetDuration":44,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":49,"whyStopped":44,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Jessa Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Group A will receive first PBM + manual lymphatic drainage for 9 weeks (2 sessions\u002Fweek), followed by 9 weeks only manual lymphatic drainage.",[13,14],"Device: Photobiomodulation therapy (PBMT)","Procedure: Manual Lymphatic drainage",{"label":16,"type":17,"description":18,"interventionNames":19},"Group B","ACTIVE_COMPARATOR","Group B will first receive only manual lymphatic drainage for 9 weeks, followed by the combination of PBM and manual lymphatic drainage for 9 weeks (2x\u002Fweek).",[13,14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Photobiomodulation therapy (PBMT)","The MLS M6 laser from ASA will be used to apply the laser therapy.",[9,16],[27],"LLLT",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Manual Lymphatic drainage","Patients will receive twice weekly MLT executed by trained physiotherapist",[9,16],[34],"MLT",[36],{"name":37,"affiliation":5,"role":38},"Jeroen Mebis, MD, PhD","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Jolien Robijns, PhD","CONTACT","011337229",null,"jolien.robijns@jessazh.be",[47,67],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hasselt University","RECRUITING","Hasselt","Limburg","3500","Belgium",{"type":55,"coordinates":56},"Point",[57,58],5.33781,50.93106,{"lat":58,"lon":57},[61,63,64],{"name":41,"role":42,"phone":44,"phoneExt":44,"email":62},"jolien.robijns@uhasselt.be",{"name":37,"role":38,"phone":44,"phoneExt":44,"email":44},{"name":65,"role":66,"phone":44,"phoneExt":44,"email":44},"Joy Lodewijckx, MSc","SUB_INVESTIGATOR",{"facility":68,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Jessa Ziekenhuis",{"type":55,"coordinates":70},[57,58],{"lat":58,"lon":57},[73,74,75],{"name":41,"role":42,"phone":44,"phoneExt":44,"email":44},{"name":37,"role":38,"phone":44,"phoneExt":44,"email":44},{"name":65,"role":66,"phone":44,"phoneExt":44,"email":44},{"type":77,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[79],{"name":48,"class":6},"100415500",false,"NCT04690439","Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema","Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial","LymphLight","Inclusion Criteria:\n\n* Diagnosed with breast cancer\n* Underwent ipsilateral lumpectomy or mastectomy + sentinel lymph node biopsy +\u002F- lymph node dissection\n* Underwent radiotherapy with or without chemotherapy\n* Diagnosed with BCRL (i.e. International Society of Lymphology (ISL) lymphedema stage I or higher)\n* Age ≥ 18 years\n* Able to comply to the study protocol\n* Able to sign written informed consent\n\nExclusion Criteria:\n\n* Metastatic disease\n* Pregnancy\n* History of surgery or trauma to the arm\n* History of arm infection in the past 3 months\n* Use of medications that affect body fluid (e.g., diuretics) in the last 3 months\n* Severe psychological disorder or dementia\n* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator","FEMALE","18 Years",{"count":90,"type":91},104,"ESTIMATED","INTERVENTIONAL",[94],"NA","Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and\u002For near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.",[97,98,99],"Breast Cancer","Breast Cancer Related Lymphedema","Lymphedema of Upper Arm",[101,102,103],"Lymphedema","Breast cancer","Photobiomodulation","2023-02-27",{"date":106,"type":107},"2023-02-28","ACTUAL",{"date":109,"type":107},"2021-02-22",{"date":111,"type":91},"2028-02",{"name":5,"class":6},2]