Immediate Lymphatic Reconstruction for Breast Cancer

Not yet recruiting at 2 trial locations

Overseen By Rachel A Karlnoski

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Male, Non-English, Axillary recurrence, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Immediate Lymphatic Reconstruction (ILR) can prevent lymphedema (swelling due to fluid build-up) in breast cancer patients undergoing lymph node removal. It compares patients receiving ILR during surgery to those having only lymph nodes removed. The trial also evaluates how ILR impacts patients' overall well-being and quality of life. Women with breast cancer who require lymph node surgery and have a high risk of developing lymphedema are suitable candidates for this study. As an unphased trial, it offers patients the opportunity to contribute to important research that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Immediate Lymphatic Reconstruction is safe for preventing breast cancer-related lymphedema?

Research has shown that Immediate Lymphatic Reconstruction (ILR) can lower the risk of lymphedema following breast cancer surgery. One study found that patients who underwent ILR were about half as likely to develop lymphedema compared to those who did not. This indicates that ILR effectively reduces the risk of this condition, which can cause arm swelling.

Regarding safety, the evidence is encouraging. Studies have not identified any major safety issues with ILR, and patients generally tolerate it well. Since ILR is performed during the existing surgery, it does not require an additional procedure, which can be reassuring for those concerned about extra risks.

In summary, ILR appears to be a safe and effective option for patients undergoing breast cancer surgery, with a strong record of reducing the risk of lymphedema. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Immediate Lymphatic Reconstruction (ILR) because it offers a proactive approach to preventing lymphedema after breast cancer surgery, which is not typically addressed with current treatment options. Unlike the standard approach that focuses on managing symptoms after they appear, ILR connects preserved lymphatic channels to nearby veins during surgery to prevent fluid buildup right from the start. This innovative technique could significantly reduce the risk of lymphedema, improving long-term outcomes and quality of life for patients.

What evidence suggests that Immediate Lymphatic Reconstruction is effective for preventing breast cancer-related lymphedema?

Research has shown that Immediate Lymphatic Reconstruction (ILR), which participants in this trial may receive, can significantly reduce the risk of developing lymphedema, a swelling caused by lymph fluid, after breast cancer surgery. One study found that only 13.3% of patients who underwent ILR developed lymphedema, compared to a higher rate in those who did not undergo the procedure. ILR works by connecting lymph channels to veins, allowing fluid to flow properly and reducing swelling. While most studies report positive outcomes, some suggest that longer follow-up is needed to confirm these benefits over time. Overall, ILR appears promising in reducing the risk of lymphedema for breast cancer patients undergoing surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for high-risk breast cancer patients who are undergoing axillary lymph node dissection (ALND). To be eligible, they must be identified by a tumor board and pass screening tests. They can't join if they don't meet the specific risk criteria or have conditions that would interfere with the study.

Inclusion Criteria

My surgery identified a lymphatic channel and a vein for bypass.

I am a woman aged 18-75 with breast cancer.

I agree to have lymph nodes removed from one side of my body, and it's been less than 6 months since my last biopsy.

Exclusion Criteria

I have had radiotherapy to the armpit area before this study or surgery.

Life expectancy < 2 years for any reason

Pregnancy or nursing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo axillary lymph node dissection (ALND) with or without Immediate Lymphatic Reconstruction (ILR) during surgery

1 day

1 visit (in-person)

Postoperative Education

Patient education by a certified lymphatic physical therapist prior to discharge

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with regular follow-up visits every three months for two years

24 months

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Immediate Lymphatic Reconstruction

Trial Overview The trial is testing Immediate Lymphatic Reconstruction (ILR) to see if it prevents lymphedema after ALND surgery. Patients will either receive ILR or standard care during surgery and then follow different postoperative monitoring protocols to compare outcomes.

How Is the Trial Designed?

Group I: ALND plus Immediate lymphatic reconstruction Experimental Treatment 1 Intervention

Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema.

Group II: ALND Alone Active Control 1 Intervention

Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12381909/

Efficacy of Immediate Lymphatic Reconstruction in ... Immediate lymphatic reconstruction (ILR) utilizes LVA during breast surgery and ALND to prevent postoperative lymphedema (Boccardo et al. 2009; ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S235258782500066X

Immediate lymphatic reconstruction for breast cancer ... Of 785 patients receiving ILR, the cumulative BCRL rate was 13.3% with a median follow-up time of 15 months. Of 696 control group patients, the cumulative BCRL ...

3. medicaljournalssweden.se medicaljournalssweden.se/JPHS/article/view/43738

The efficacy of immediate lymphatic reconstruction in ... Immediate lymphatic reconstruction (ILR) has emerged as an effective intervention to reduce breast cancer-related lymphedema, which affects 2–30% of patients.

4. abs.amegroups.org abs.amegroups.org/article/view/8268/html

Immediate lymphatic reconstruction: an overview - Huang Early clinical outcomes show that ILR reduces the incidence of lymphedema, though short follow up times and heterogeneity between studies make it difficult to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12222251/

Long-Term Outcomes of Lymphedema After Immediate ... Preliminary studies have shown promising results with ILR in reducing the incidence of BCRL.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12123365/

Immediate lymphatic reconstruction for breast cancer ... This systematic review revealed an overall relative risk (RR) of 0.51 of developing BCRL in patients receiving ILR after axillary lymph node ...

7. link.springer.com link.springer.com/article/10.1245/s10434-025-17301-0

Long-Term Outcomes of Lymphedema After Immediate ... Despite advancements in breast cancer therapies and surgical techniques, the risk of developing lymphedema is 30% to 50% after axillary lymph ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04241341?term=NCT04241341&rank=1

Does Immediate Lymphatic Reconstruction Decrease the ... Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681525004097

Immediate lymphatic reconstruction for prevention of ... ILR reduces the risk of cancer-related secondary lymphedema, particularly for breast cancer patients in the early postoperative period.

10. gs.amegroups.org gs.amegroups.org/article/view/122741/html

Immediate lymphatic reconstruction for breast cancer-related ... Breast cancer-related lymphedema (BCRL) after axillary lymph node dissection (ALND) has reportedly reduced patients' quality of life (1,2).