LYMPHA Procedure for Lymphedema

Overseen By David Perrault, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Primary lymphedema, Radiotherapy, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special procedure can reduce the risk of lymphedema, a painful swelling condition, after breast cancer surgery involving lymph node removal. The study tests three approaches: lymph node removal alone, with added tissue support, and with immediate lymphatic reconstruction using a special mapping technique called the LYMPHA procedure. It is suitable for those who have had or will have breast cancer surgery that includes lymph node removal. Participants should not have existing limb swelling or have undergone radiation in the armpit area before the trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve post-surgery outcomes for future patients.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that the LYMPHA procedure is safe for lymphedema patients?

Research has shown that immediate lymphatic reconstruction (ILR) can reduce the risk of developing lymphedema after axillary lymph node 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 can effectively reduce swelling problems.

The risk of lymphedema after axillary surgery can reach up to 32% over two years. However, ILR has been shown to help manage this risk. Procedures like LYMPHA aim to improve outcomes by rebuilding the lymphatic system during surgery.

Despite these benefits, surgery involving axillary lymph nodes remains a major risk factor for lymphedema. While ILR can help, it does not completely eliminate the risk.

In summary, the procedure is generally well-tolerated and can significantly lower the risk of lymphedema, but the surgery itself still carries a significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LYMPHA procedure for lymphedema because it offers a fresh approach by incorporating immediate lymphatic reconstruction. Unlike traditional methods, which often involve lymphadenectomy alone or with soft tissue reinforcement, LYMPHA uses reverse mapping with the SPY System to precisely reconstruct lymphatic pathways during surgery. This technique aims to prevent lymphedema by maintaining lymphatic drainage, potentially reducing the risk of swelling and discomfort that patients typically face after lymph node removal. By addressing the root cause of lymphedema right at the time of surgery, this method could significantly improve patient outcomes.

What evidence suggests that the LYMPHA procedure is effective for reducing lymphedema?

Research has shown that immediate lymphatic reconstruction (LYMPHA), a treatment studied in this trial, can reduce the risk of lymphedema, a condition causing swelling after breast cancer surgery. This technique reconnects the lymphatic channels often disrupted during surgery. Studies have found that LYMPHA lowers the chances of developing lymphedema, which affects up to 50% of patients post-surgery. Specifically, one study found that LYMPHA can prevent arm swelling and improve recovery. Overall, evidence suggests that LYMPHA is a promising option for managing and preventing lymphedema in breast cancer patients. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for breast cancer patients undergoing axillary lymphadenectomy without distant metastasis, regardless of preoperative chemotherapy or histology results. Participants must be willing to consent and follow study procedures, have no severe kidney or liver issues, no recent substance abuse or psychiatric disease, not pregnant/nursing, and free from conditions causing limb swelling.

Inclusion Criteria

Histology results of axillary lymph nodes could be either Negative or Positive

Willingness and ability to provide written informed consent

I have had chemotherapy before surgery.

Exclusion Criteria

Absolute neutrophil count < 1500 mm3 at screening

Hemoglobin concentration < 9 g/dL at screening

My liver tests are higher than normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo axillary lymphadenectomy with or without lymphatic reconstruction procedures

Immediate post-surgery

Follow-up

Participants are monitored for limb volume, skin thickness, bioimpedance, quality of life, and lymphatic flow pattern

2 years

What Are the Treatments Tested in This Trial?

Interventions

• axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)

Trial Overview The study compares three approaches: standard axillary lymphadenectomy; the same procedure with soft tissue reinforcement; and immediate LYMPHA reconstruction. The goal is to see if LYMPHA reduces the risk of developing lymphedema post-surgery and improves patient outcomes and quality of life.

How Is the Trial Designed?

Group I: Group C Experimental Treatment 1 Intervention

Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System.

Group II: Group A Experimental Treatment 1 Intervention

Group A will under axillary lymphadenectomy alone

Group III: Group B Active Control 2 Interventions

Group B will undergo axillary lymphadenectomy with soft tissue reinforcement(STR)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

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

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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798324014458

The efficacy of immediate lymphatic reconstruction after ... Using pooled data, we can conclude that immediate lymphatic reconstruction decreases the risk of developing lymphedema following ALND for breast cancer.

3. medicaljournalssweden.se medicaljournalssweden.se/JPHS/article/view/43738/50854

View of The efficacy of immediate lymphatic reconstruction ... Based on our study and the existing literature, ILR appears to be effective in reducing secondary lymphedema following axillary surgery for breast cancer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12301833/

Effectiveness of the lymphatic microsurgical preventive ... Conclusion. Performing immediate lymphatic reconstruction with LyMPHA after ALND may prevent arm lymphedema and reduce morbidity in patients ...

5. jprasurg.com jprasurg.com/article/S1748-6815(24)00771-X/fulltext

Immediate lymphatic reconstruction with targeted ... However, the risk of lymphedema due to axillary surgery remains significant, reaching up to 32% after 2 years. 1. Ribeiro Pereira, A.C.P.

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

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 dissection. The RR ...

7. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/0c0ca7ad-1561-4bde-87b2-c017eb93bfa7/download

Long-Term Outcomes of Lymphedema After Immediate ... Lymphedema rates following axillary lymph node dissection with and without immediate lymphatic reconstruction: a prospective trial. Ann. Surg ...

8. mdpi.com mdpi.com/2813-3307/3/3/18

Immediate Lymphatic Reconstruction: The Value of a Two ... Axillary lymph node dissection (ALND) is the greatest independent risk factor for lymphedema, with a risk of BCRL of 14–26%. The risk is nearly four times that ...