ILR to Prevent BRCL_MCC 23608
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: D
| Condition(s) | Breast Cancer Lymphedema |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 spectros |
| Who can participate | 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 th |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Lead sponsor | University of South Florida |
| Locations | Tampa, Florida, United States; Tampa, Florida, United States; Tampa, Florida, United States |
| Start date | 2025-10-01 |
| NCT ID | NCT07127003 |
| Official listing | https://clinicaltrials.gov/study/NCT07127003 |