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NCT07127003
ILR to Prevent BRCL_MCC 23608
NA trial testing Immediate Lymphatic Reconstruction in Breast Cancer Lymphedema in 98 participants. Not yet recruiting.
1 October 2026
Quick facts
| Lead sponsor | University of South Florida |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 98 |
| Start date | 1 October 2025 |
| Primary completion | 1 October 2026 |
| Estimated completion | 1 October 2027 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Immediate Lymphatic Reconstruction
Conditions studied
- Breast Cancer Lymphedema — all drugs for Breast Cancer Lymphedema →
Sponsor
University of South Florida
Who can join
Adults 18 to 75, female only, with Breast Cancer Lymphedema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 on breast cancer patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07127003
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Immediate Lymphatic Reconstruction
Trials testing the same drug.
- NCT06144164 — A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With B · Phase 3 · recruiting
Other recruiting trials for Breast Cancer Lymphedema
Currently open trials in the same condition.
- NCT07420725 — The Relationship Between Gait Parameters and Balance Disorder and Fall Risk in Breast Cancer-Related Lymphedema(BCRL) · active not recruiting
- NCT06302361 — Lymphovenous Anastomosis for Breast Cancer Lymphedema · NA · active not recruiting
- NCT05725265 — LLLT for BCRL: a Randomized, Placebo-controlled Study · NA · recruiting
- NCT05983380 — The Effect of Hand Exercises on Upper Limb Volume, Quality of Life, and Hand Function in Breast Cancer Survivors · NA · recruiting
- NCT05441943 — Lymphaticovenous Anastomosis as Treatment for Lymphedema · NA · active not recruiting
Other University of South Florida trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07127003 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of South Florida
- Last refreshed: 17 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07127003.
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