[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054088":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":53,"collaborators":56,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":21,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":21,"enrollmentInfo":73,"targetDuration":21,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":84,"whyStopped":21,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Compression therapy","EXPERIMENTAL","Participants will receive a ready to wear compression sleeve and glove with embedded sensor.\n\nCompression sleeve will be set to 20-30mm Hg pressure with instructions to wear for 12 hours a day for four consecutive weeks.\n\nParticipants will also receive a journal to record usage and standard of care post-operative lymphedema monitoring and education and asked to fill out questionnaires.",[13,14],"Device: Juzo Compression Sleeve and Glove","Device: Compression Sleeve Sensor",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Juzo Compression Sleeve and Glove","Elasticized garment sized for arm and hand to create pressure to reduce swelling",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Compression Sleeve Sensor","Small device embedded within compression sleeve garment collecting usage information",[9],[27],{"name":28,"affiliation":5,"role":29},"Alphonse G Taghian, MD, PhD","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},"CONTACT","617-726-6050","ataghian@mgh.harvard.edu",[36],{"facility":37,"status":21,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Massachusetts General Hospital Cancer Center","Boston","Massachusetts","02114","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-71.05977,42.35843,{"lat":47,"lon":46},[50,52],{"name":51,"role":32,"phone":33,"phoneExt":21,"email":34},"Alphonse G Taghian, MD PhD",{"name":51,"role":29,"phone":21,"phoneExt":21,"email":21},{"type":29,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Alphonse Taghian","Principal Investigator",[57,60,62],{"name":58,"class":59},"Heinz Family Foundation","UNKNOWN",{"name":61,"class":59},"Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema",{"name":63,"class":59},"Olayan-Xefos Family Fund for Breast Cancer Research","100054088","early-intervention-100054088",false,"NCT05326165","Early Intervention","Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study","Inclusion Criteria:\n\n* Eligible participants will be female, \\>\u002F= 18 years, who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (ALND) (with or without contralateral prophylactic SLNB). Because of the extremely low incidence of BC in children and males, only female participants over the age of 18 will be included.\n* Eligible participants will demonstrate low volume swelling (RVC 5-\\\u003C10%) \\>\u002F=12 weeks postoperatively\n* Eligible participants will read and comprehend English, with the ability to understand and the willingness to sign a written consent document.\n* Most patients treated for breast cancer will have undergone SLNB for axillary staging, and are therefore at lower risk for BCRL, compared to patients with ALND and\u002For regional lymph node radiation (RLNR). We have chosen to include only patients at high risk of BCRL, i.e., those who have undergone ALND, and we will not be including those who are at low BCRL risk, i.e., had only SLNB for axillary staging on the side of BC.\n\nExclusion Criteria:\n\n* Participants who have bilateral BC (ie. contralateral staging SLNB or ALND) will not be eligible due to the need of a contralateral control arm for the RVC equation.\n* Participants will not be eligible if they have been diagnosed and\u002For treated for BCRL.\n* Participants will not be eligible if they have metastases that may cause BCRL. Participants with metastatic disease will be excluded.\n* Participants with implanted cardiac devices and those who are pregnant will be excluded from the Sozo measurement component of the study.","FEMALE","18 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"NA","This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.",[81,82],"Breast Cancer","Breast Cancer Treatment Related Lymphedema",[81,82],"NOT_YET_RECRUITING","2026-07-09",{"date":87,"type":88},"2026-07-13","ACTUAL",{"date":90,"type":75},"2027-05",{"date":92,"type":75},"2027-06-30",{"name":5,"class":6},1]