Condition: Breast Cancer Lymphedema · Sponsor: University of South Florida
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 randomly assigned to one of two groups: Intervention Group (Study Arm A): Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema. Control Group (Study Arm B): Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery. Patients will be blinded to their group assignment. Post-surgery, all participants will receive education from a certified lymphatic physical therapist. At the 2-week postoperative visit, participants will be further randomized into two postoperative monitoring protocols: BCRL …
This description comes directly from the study's public registry record.
NIcholas Panetta, MD · 8134868073 · panetta@usf.edu
Rachel A Karlnoski · 7278584224 · karlnosk@usf.edu
Always discuss trial participation with your own doctor first.
| Tampa General Hospital | Tampa, Florida, United States | Recruiting |
| Moffitt Cancer Center | Tampa, Florida, United States | Recruiting |
| University of South Florida | Tampa, Florida, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07127003