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NCT07127003 · ClinicalTrials.gov registry record · NA
ILR to Prevent BRCL_MCC 23608
A NA study, sponsored by University of South Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 98
- Enrollment target
NCT07127003 is a NA study that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 98 participants.
The verdict
NCT07127003, a NA study, is actively recruiting participants, sponsored by University of South Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
Study 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 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 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). Standard of Care: Patients will be monitored only if they experience BCRL symptoms or after two years from ALND. The 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
Interventions
- PROCEDURE Immediate Lymphatic Reconstruction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2027-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07127003
The ClinicalTrials.gov registry entry for NCT07127003 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Immediate Lymphatic Reconstruction is the first listed.
NCT07127003 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07127003 about?
NCT07127003 is a clinical study titled "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 a...
What is the current status of trial NCT07127003?
This trial is currently recruiting. It is a NA study. The enrollment target is 98 participants. The study started on 2025-10-01. Estimated completion is 2027-10-01.
What interventions are being tested in trial NCT07127003?
The interventions under investigation include: Immediate Lymphatic Reconstruction (PROCEDURE).
Who is sponsoring clinical trial NCT07127003?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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