[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602706":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":71,"collaborators":18,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":18,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":18,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of South Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ALND plus Immediate lymphatic reconstruction","EXPERIMENTAL","Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema.",[13],"Procedure: Immediate Lymphatic Reconstruction",{"label":15,"type":16,"description":17,"interventionNames":18},"ALND Alone","NO_INTERVENTION","Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Immediate Lymphatic Reconstruction","Preserved lymphatic channels are connected to nearby veins to prevent lymphedema during the axillary lymph node dissection.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"NIcholas Panetta, MD","CONTACT","8134868073","panetta@usf.edu",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Rachel A Karlnoski","7278584224","karlnosk@usf.edu",[36,55,61],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Tampa General Hospital","RECRUITING","Tampa","Florida","33606","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-82.45843,27.94752,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":53,"phoneExt":18,"email":54},"Rachel A Karlnoski, PhD","727-858-4224","c-rkarlnoski@tgh.org",{"facility":56,"status":38,"city":39,"state":40,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":60,"contacts":18},"Moffitt Cancer Center","33612",{"type":45,"coordinates":59},[47,48],{"lat":48,"lon":47},{"facility":5,"status":38,"city":39,"state":40,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},{"type":45,"coordinates":63},[47,48],{"lat":48,"lon":47},[66,68],{"name":67,"role":28,"phone":18,"phoneExt":18,"email":34},"Rachel Karlnoski, PhD",{"name":69,"role":70,"phone":18,"phoneExt":18,"email":18},"Nicholas Panetta, MD","PRINCIPAL_INVESTIGATOR",{"type":72,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100602706","ilr-to-prevent-brclmcc-23608-100602706",false,"NCT07127003","ILR to Prevent BRCL_MCC 23608","Prospective, Randomized Clinical Trial for Immediate Lymphatic Reconstruction to Prevent Breast Cancer Related Lymphedema","Inclusion Criteria:\n\n* Patients consenting for unilateral ALND \\[prior history of sentinel lymph node biopsy (SLNBx) allowed if \\\u003C6 months from consent\\]\n* Patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon\n* Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery\n* Female breast cancer patients 18-75 years of age (inclusive)\n\nExclusion Criteria:\n\n* • Male breast cancer patients\n\n  * Non-English speaking participants\n  * Female breast cancer patients with axillary recurrence\n  * Female breast cancer patients who have a history of ALND\n  * Female patients requiring bilateral ALND for the treatment of their breast cancer\n  * Female breast patients treated with SLNBx only\n  * Primary lymphedema of the affected upper limb\n  * Secondary lymphedema of the affected limb prior to the lymphadenectomy\n  * Radiotherapy at the axilla before the study \u002F surgery\n  * Life expectancy \\\u003C 2 years for any reason\n  * Pregnancy or nursing\n  * Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening\n  * Severe psychiatric disease\n  * Distant metastases at the time of preoperative screening","FEMALE","18 Years","75 Years",{"count":84,"type":85},98,"ESTIMATED","INTERVENTIONAL",[88],"NA","The goal of this clinical trial is to evaluate the effectiveness of Immediate Lymphatic Reconstruction (ILR) in preventing breast cancer-related lymphedema (BCRL) in high-risk patients. It will also assess the safety and quality of life outcomes associated with the procedure. The main questions it aims to answer are:\n\nDoes ILR reduce the incidence of BCRL in patients undergoing axillary lymph node dissection (ALND)?\n\nWhat are the patient-reported outcomes and quality of life differences between those who receive ILR and those who do not?\n\nParticipants will be identified as high-risk for developing BCRL through a multidisciplinary tumor board and referred to a specialized clinic for further evaluation. High-risk patients will undergo a series of screening tests, including bioimpedance spectroscopy (BIS), circumferential limb measurements, and infrared 3D perometry.\n\nParticipants will be randomly assigned to one of two groups:\n\nIntervention Group (Study Arm A): Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema.\n\nControl Group (Study Arm B): Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery.\n\nPatients will be blinded to their group assignment. Post-surgery, all participants will receive education from a certified lymphatic physical therapist.\n\nAt the 2-week postoperative visit, participants will be further randomized into two postoperative monitoring protocols:\n\nBCRL Clinical Pathway: Patients will have regular follow-up visits every three months for two years, including repeat BIS, limb measurements, perometry, and quality of life questionnaires (LYMQOL and ULL-27).\n\nStandard of Care: Patients will be monitored only if they experience BCRL symptoms or after two years from ALND.\n\nThe study will compare the outcomes of both groups, with a focus on the incidence of BCRL and patient quality of life, and will benchmark these results against published literature on breast cancer patients.",[91],"Breast Cancer Lymphedema",[93,94,95],"Axillary lymph node dissection","breast cancer","lymphedema","2026-04-29",{"date":98,"type":99},"2026-04-30","ACTUAL",{"date":101,"type":99},"2025-10-01",{"date":103,"type":85},"2027-10-01",{"name":5,"class":6},3]