[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06144164":3,"trial-entities:NCT06144164":175,"trial-summary:NCT06144164":178},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":24,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":62,"secondary_outcomes":67,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":89,"locations":92,"central_contacts":161,"overall_officials":168,"references":171,"see_also_links":172},"NCT06144164","23-303","A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer","A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life","RECRUITING","2030-03-16","2025-11","2025-11-10","2023-11-16","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.",[18,19,20,21,22,23],"Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Breast Cancer","Breast Carcinoma","Female Breast Cancer",[25,26,18,19,20,27,28,29,13,5],"immediate lymphatic reconstruction","axillary lymph node dissection","Breast cancer","breast carcinoma","female breast cancer","INTERVENTIONAL","PREVENTION",[33],"PHASE3",{"count":35,"type":36},285,"ESTIMATED",[38,46,51,55,58],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":44},"PROCEDURE","Immediate Lymphatic Reconstruction","Immediate Lymphatic Reconstruction will happen at the time of Axillary Lymph Node Dissection",[43],"Participants with Breast Cancer",[45],"ILR",{"type":47,"name":48,"description":49,"armGroupLabels":50},"DIAGNOSTIC_TEST","Volumetric arm measurements","Volumetric arm measurements will occur at each in-person postoperative visit time points.",[43],{"type":14,"name":52,"description":53,"armGroupLabels":54},"Lymphatic massage","Participants will begin self-directed lymphatic massage 24 to 48 h after surgery and will continue to do lymphatic massage 3 times a week for 3 months after surgery or until 3 months after any adjuvant treatments (chemotherapy, radiation, etc.) are completed",[43],{"type":14,"name":56,"description":53,"armGroupLabels":57},"Range of motion exercises",[43],{"type":14,"name":59,"description":60,"armGroupLabels":61},"Compression garment use","Participants will use compression garments 24 to 48 h after surgery and will continue daily use for at least 8 h a day for 3 months or until 3 months after any adjuvant treatments are completed",[43],[63],{"measure":64,"description":65,"timeFrame":66},"The difference between the baseline and postoperative arm volume measurement","The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection\u002FALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema","Up to 24 months",[],"FEMALE","18 Years","75 Years",false,{"inclusion":73,"exclusion":78,"raw_text":88},[74,75,76,77],"Female sex","Diagnosis of breast cancer","Ages 18 to 75 years","Consented for unilateral ALND or for unilateral SLNB with possible ALND",[79,80,81,82,83,84,85,86,87],"Male sex","Does not speak English","Does not fit into study garment","Axillary recurrence","History of ALND","Requirement of bilateral ALND for the treatment of breast cancer","Treatment with SLNB only","Known anaphylactic allergy to ICG dye used in ILR","Impaired decision-making capacity","Inclusion Criteria:\n\n* Female sex\n* Diagnosis of breast cancer\n* Ages 18 to 75 years\n* Consented for unilateral ALND or for unilateral SLNB with possible ALND\n\nExclusion Criteria:\n\n* Male sex\n* Does not speak English\n* Does not fit into study garment\n* Axillary recurrence\n* History of ALND\n* Requirement of bilateral ALND for the treatment of breast cancer\n* Treatment with SLNB only\n* Known anaphylactic allergy to ICG dye used in ILR\n* Impaired decision-making capacity",[90,91],"ADULT","OLDER_ADULT",[93,107,116,125,135,144,152],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":104},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[100],{"name":101,"role":102,"phone":103},"Michelle Coriddi, MD","CONTACT","646-608-8042",{"lat":105,"lon":106},40.70621,-74.54932,{"facility":108,"status":8,"city":109,"state":96,"zip":110,"country":98,"contacts":111,"geoPoint":113},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",[112],{"name":101,"role":102,"phone":103},{"lat":114,"lon":115},40.39428,-74.11709,{"facility":117,"status":8,"city":118,"state":96,"zip":119,"country":98,"contacts":120,"geoPoint":122},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",[121],{"name":101,"role":102,"phone":103},{"lat":123,"lon":124},41.04676,-74.02292,{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":98,"contacts":130,"geoPoint":132},"Memorial Sloan Kettering Commack (Limited Protocol Activities)","Commack","New York","11725",[131],{"name":101,"role":102,"phone":103},{"lat":133,"lon":134},40.84288,-73.29289,{"facility":136,"status":8,"city":137,"state":128,"zip":138,"country":98,"contacts":139,"geoPoint":141},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",[140],{"name":101,"role":102,"phone":103},{"lat":142,"lon":143},40.96899,-73.71263,{"facility":145,"status":8,"city":128,"state":128,"zip":146,"country":98,"contacts":147,"geoPoint":149},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[148],{"name":101,"role":102,"phone":103},{"lat":150,"lon":151},40.71427,-74.00597,{"facility":153,"status":8,"city":154,"state":128,"zip":155,"country":98,"contacts":156,"geoPoint":158},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",[157],{"name":101,"role":102,"phone":103},{"lat":159,"lon":160},40.70038,-73.59291,[162,164],{"name":101,"role":102,"phone":103,"email":163},"coriddim@mskcc.org",{"name":165,"role":102,"phone":166,"email":167},"Babak Mahrara, MD","646-608-8085","mehrarab@MSKCC.ORG",[169],{"name":101,"affiliation":13,"role":170},"PRINCIPAL_INVESTIGATOR",[],[173],{"label":13,"url":174},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":176,"biomarkers":177},[22],[],{"nct_id":4,"found":179,"summary":180,"prompt_version":190},true,{"design":181,"status":182,"heading":183,"summary":184,"follow_up":185,"word_count":186,"commitments":187,"compensation":188,"drugs_mentioned":189},"This interventional study plans to enroll 285 women. It is designed to test a comprehensive program to prevent lymphedema.","completed","Preventing Lymphedema After Breast Cancer Surgery","This study is testing a comprehensive program to help prevent lymphedema (swelling caused by fluid buildup) in the arm after surgery for breast cancer. The program includes Immediate Lymphatic Reconstruction (a surgical procedure), self-directed lymphatic massage, range of motion exercises, and wearing a compression garment. Researchers want to see if these interventions can help lymph fluid drain properly and reduce the risk of lymphedema. You may be able to join if you are a woman between 18 and 75 years old with breast cancer who will have axillary lymph node dissection (ALND) surgery. The study will measure arm swelling for up to 24 months to see how well the program works. The current recruitment status is unclear.","Your arm volume will be measured at each in-person postoperative visit for up to 24 months after surgery.",117,"You would undergo Immediate Lymphatic Reconstruction during your ALND surgery. You would also perform self-directed lymphatic massage and range of motion exercises three times a week, and wear a compression garment daily for at least 8 hours, for three months after surgery or until three months after any additional treatments.","Not stated in the trial record.",[40,52,56],"v2"]