Immediate Lymphatic Reconstruction to prevent breast cancer–related lymphedema
Prospective, Randomized Clinical Trial for Immediate Lymphatic Reconstruction to Prevent Breast Cancer Related Lymphedema
This will test whether doing Immediate Lymphatic Reconstruction during axillary lymph node removal can prevent lymphedema in women at high risk after breast cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of South Florida Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Tampa, Florida and 2 other locations) |
| Trial ID | NCT07127003 on ClinicalTrials.gov |
What this trial studies
This is a randomized, blinded trial enrolling high-risk women identified by a multidisciplinary tumor board who are undergoing or likely to require axillary lymph node dissection. Participants undergo baseline lymphedema screening with bioimpedance spectroscopy, circumferential limb measurements, and 3D infrared perometry, then are randomized to ILR performed at the time of ALND or to no ILR. Surgery uses RAM to identify lymphatic channels and a microvascular lymphatic-to-venous bypass is performed when suitable lymphatics and veins are found. The study will compare incidence of breast cancer–related lymphedema, safety outcomes, and patient-reported quality of life between the two arms.
Who should consider this trial
Good fit: Women aged 18–75 undergoing or likely to require unilateral axillary lymph node dissection for breast cancer who are identified as high-risk by the tumor board and meet intraoperative criteria for lymphatic bypass are ideal candidates.
Not a fit: Patients with prior ALND, existing ipsilateral lymphedema, those only treated with sentinel node biopsy, those requiring bilateral ALND, male patients, or non-English speakers (per protocol exclusions) would not be expected to benefit from this study.
Why it matters
Potential benefit: If successful, adding ILR at the time of axillary dissection could substantially reduce the rate of lymphedema and help preserve arm function and quality of life for high-risk patients.
How similar studies have performed: Single-center and observational series of immediate lymphatic reconstruction (LYMPHA) have reported lower lymphedema rates, but randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampa, Florida and 2 other locations
- 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)
Study contacts
- Study coordinator: NIcholas Panetta, MD
- Email: panetta@usf.edu
- Phone: 8134868073
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.