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ILR to Prevent BRCL_MCC 23608

RecruitingNAAges 18 Years - 75 YearsFemaleUniversity of South Florida
NCT07127003 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: Does ILR reduce the incidence of BCRL in patients undergoing axillary lymph node dissection (ALND)? What are the patient-reported outcomes and quality of life differences between those who receive ILR and those who do not? Participants 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. Participants will be r

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients consenting for unilateral ALND \[prior history of sentinel lymph node biopsy (SLNBx) allowed if \<6 months from consent\] * 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 * 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 * Female breast cancer patients 18-75 years of age (inclusive) Exclusion Criteria: * • Male breast cancer patients * Non-English speaking participants * Female breast cancer patients with axillary recurrence * Female breast cancer patients who have a history of ALND * Female patients requiring bilateral ALND for the treatment of their breast cancer * Female breast patients treated with SLNBx only * Primary lymphedema of the affected upper limb * Secondary lymphedema of the affected limb prior to the lymphadenectomy * Radiotherapy at the axilla before the study / surgery * Life expectancy \< 2 years for any reason * Pregnancy or nursing * Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening * Severe psychiatric disease * Distant metastases at the time of preoperative screening
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What it tests

  • Immediate Lymphatic Reconstruction
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Where

3 sites
Tampa General Hospital
Tampa, United States
Moffitt Cancer Center
Tampa, United States
University of South Florida
Tampa, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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