Lymphedema Prevention Program for Breast Cancer

Recruiting at 6 trial locations

Overseen By Babak Mahrara, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Male, Non-English speakers, Axillary recurrence, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

285 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special program can reduce the risk of lymphedema (swelling from lymph fluid buildup) in people with breast cancer. The treatment involves Immediate Lymphatic Reconstruction, a procedure that helps lymph fluid drain properly from the arm. Women with breast cancer planning certain types of lymph node surgery might be suitable for this trial. Participants should have no history of similar surgeries or allergies to the dye used in the procedure. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that immediate lymphatic reconstruction (ILR) is generally safe for breast cancer patients. This procedure reduces the risk of lymphedema, which is swelling caused by a buildup of lymph fluid after surgery. In one study of 785 patients who underwent ILR, only 13.3% developed lymphedema within 15 months, a significant decrease compared to those who did not have the procedure. Another study found that ILR is safe and improves recovery and quality of life for patients. These findings suggest that ILR is well-tolerated and effective in preventing lymphedema after breast cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for lymphedema, which often focus on managing symptoms after they occur, Immediate Lymphatic Reconstruction aims to prevent the condition from developing in the first place. This procedure is performed at the time of breast cancer surgery, specifically during axillary lymph node dissection, to preserve lymphatic function and reduce the risk of lymphedema. Researchers are excited about this proactive approach because it has the potential to significantly improve quality of life by preventing a condition that can be challenging to manage once it starts.

What evidence suggests that this trial's treatments could be effective for preventing lymphedema in breast cancer patients?

Research has shown that Immediate Lymphatic Reconstruction (ILR), which participants in this trial may receive, can help prevent lymphedema in breast cancer patients. One study found that only 13.3% of patients who underwent ILR developed lymphedema, compared to those who did not have the procedure, suggesting it may offer protection. Other studies support this, indicating that ILR can lower the risk of lymphedema after surgery. While early results are promising, more time is needed to confirm these benefits. Overall, ILR appears to be a promising way to reduce the risk of lymphedema and improve quality of life. ^{6 7 8 9 10}

Who Is on the Research Team?

Michelle Coriddi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for women aged 18-75 with breast cancer who are undergoing or may undergo axillary lymph node dissection (ALND). They must be able to consent and speak English. It's not open to men, those allergic to ICG dye used in one of the procedures, patients needing bilateral ALND, those treated with SLNB only, have axillary recurrence or a history of ALND, or have impaired decision-making capacity.

Inclusion Criteria

I am female.

I have agreed to undergo a specific type of lymph node removal surgery.

I have been diagnosed with breast cancer.

Exclusion Criteria

I need both sides of my armpit lymph nodes removed for breast cancer treatment.

I have only had a sentinel lymph node biopsy.

You are allergic to the ICG dye used in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo axillary lymph node dissection and participate in a comprehensive prevention program to reduce lymphedema

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with arm volume measurements to assess lymphedema development

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Compression garment use
• Immediate Lymphatic Reconstruction
• Lymphatic massage
• Range of motion exercises
• Volumetric arm measurements

Trial Overview The study tests a comprehensive prevention program that includes lymphatic massage, immediate lymphatic reconstruction surgery (ILR), volumetric arm measurements to track swelling, use of compression garments, and range-of-motion exercises. The goal is to see if these combined efforts can prevent lymphedema after breast cancer surgery.

How Is the Trial Designed?

Group I: Participants with Breast Cancer Experimental Treatment 5 Interventions

Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.

Immediate Lymphatic Reconstruction is already approved in European Union, United States for the following indications:

Approved in European Union as LYMPHA for:

• Prevention of breast cancer-related lymphedema

Approved in United States as ILR for:

• Prevention of breast cancer-related lymphedema

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 11 breast cancer patients who underwent immediate lymphatic reconstruction (ILR) and received adjuvant radiation therapy, 64% had their ILR site within the radiation field, receiving a median dose of 4280 cGy, which raises concerns about the risk of lymphedema.

Even for patients whose ILR sites were outside the planned radiation fields, they still received some radiation exposure (median dose of 233 cGy), indicating a need for strategies to minimize radiation to these critical areas during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying radiation in the axillary bed at the site of lymphedema surgical prevention. Friedman, R., Spiegel, DY., Kinney, J., et al.[2023]

In a study of 213 patients who underwent mastectomy for breast cancer, immediate lymphatic reconstruction (ILR) showed a promising reduction in the incidence of upper extremity lymphedema, with only 3.8% of patients in the treatment group developing lymphedema compared to 7.7% in the control group.

The successful implementation of ILR in 86.7% of cases suggests its potential effectiveness, although further research with larger sample sizes and longer follow-up is needed to confirm these preliminary findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the preventive effect of immediate lymphatic reconstruction on the upper extremity lymphedema. Chung, JH., Kwon, SH., Jung, SP., et al.[2023]

Immediate lymphatic reconstruction (ILR) significantly reduces the risk of developing lymphedema in breast cancer patients undergoing axillary lymph node dissection, lowering the risk to just 6.6%.

Lymphedema affects a large number of people worldwide and can severely impact quality of life, making ILR a promising prophylactic approach that warrants further long-term studies to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Lymphatic Reconstruction to Prevent Breast Cancer-Related Lymphedema: A Systematic Review. Cook, JA., Sinha, M., Lester, M., et al.[2022]

Immediate lymphatic reconstruction (ILR) is a proactive strategy aimed at preventing lymphedema in breast cancer survivors, addressing a significant gap in improving their quality of life.

The article discusses the Calgary experience in developing an ILR program, emphasizing the importance of team collaboration, surgical techniques, and patient follow-up to enhance the effectiveness of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitigating Breast-Cancer-Related Lymphedema-A Calgary Program for Immediate Lymphatic Reconstruction (ILR). Deban, M., McKinnon, JG., Temple-Oberle, C.[2023]

A significant portion of major U.S. insurance providers (42.9%) do not have publicly available policies on Immediate Lymphatic Reconstruction (ILR), and among those that do, 75% deny coverage for the procedure.

In a specific institutional analysis, nearly all charges for ILR ($166,118.99 out of $170,071.80) were denied by insurance, highlighting a critical gap in coverage that may hinder access to this preventive treatment for breast cancer-related lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

United States insurance coverage of immediate lymphatic reconstruction. La-Anyane, O., Alba, BE., Harmon, KA., et al.[2023]

Immediate lymphatic reconstruction (ILR) shows a low incidence of secondary lymphedema, with rates of 2.7% for upper extremity procedures and 3.6% for lower extremity procedures among 789 patients studied across 13 trials.

The technique, particularly the lymphatic microsurgical preventive healing approach (LYMPHA), may effectively facilitate lymphatic drainage during surgery, but further research is needed to confirm its long-term efficacy and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Lymphatic Reconstruction for Prevention of Secondary Lymphedema: A Meta-Analysis. Chun, MJ., Saeg, F., Meade, A., et al.[2022]

In a randomized controlled trial involving 144 women undergoing axillary lymph node dissection for breast cancer, immediate lymphatic reconstruction (ILR) significantly reduced the incidence of breast cancer-related lymphedema (BCRL) to 9.5% compared to 32% in the control group, indicating its efficacy in preventing this condition.

Patients who received ILR also experienced lower bioimpedance values, reduced need for compression garments, improved lymphatic function, and better quality of life, suggesting that ILR not only decreases BCRL incidence but also enhances overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Immediate Lymphatic Reconstruction to Decrease Incidence of Breast Cancer-related Lymphedema: Preliminary Results of Randomized Controlled Trial. Coriddi, M., Dayan, J., Bloomfield, E., et al.[2023]

In a study of 90 patients undergoing axillary lymph node dissection (ALND) with immediate lymphatic reconstruction (ILR), successful ILR significantly reduced the rate of breast cancer-related lymphedema (BCRL) to 10.9%, compared to 66.7% in cases where ILR was aborted and 50.2% in historical benchmarks.

The study also found that factors such as smoking, fewer lymphatic channels, and higher body mass index (BMI) were associated with a higher likelihood of ILR being aborted, indicating that patient characteristics can influence the success of this preventative procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment and Feasibility of an Immediate Lymphatic Reconstruction Program in a Community Health System. Haravu, PN., Shakir, A., Jackson, K., et al.[2023]

Immediate lymphatic reconstruction (ILR) significantly reduces the incidence of breast cancer-related lymphedema (BCRL), with only 4.8% of patients undergoing ILR developing lymphedema compared to 24.1% in those who did not receive ILR.

Patients who did not undergo ILR had over 10 times higher odds of developing lymphedema, highlighting the effectiveness of ILR as a preventive measure during axillary lymph node dissection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Immediate Lymphatic Reconstruction in Prevention of Breast Cancer-Related Lymphedema. Le, NK., Liu, L., Jesus Cruz, R., et al.[2023]

Citations

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

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

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12432931/

Immediate lymphatic reconstruction (ILR) for prevention of ... There is a definite indication that ILR is beneficial in preventing BCRL. This might be a helpful intervention for improving the quality of life ...

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. medicaljournalssweden.se medicaljournalssweden.se/JPHS/article/download/43738/50854?inline=1

The efficacy of immediate lymphatic reconstruction in ... Conclusion: Our study emphasizes ILR's efficacy over extended follow-up. The ILR group exhibited a lower rate of postoperative lymphedema, supporting ILR as an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11002484/

Immediate lymphatic reconstruction for breast cancer- ... In 2009, Boccardo et al. reported the concept of ILR as the lymphedema microsurgical prevention healing approach (LYMPHA) and showed positive results with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625005570

Effectiveness of the lymphatic microsurgical preventive ... This large single-center cohort study supports wider adoption of LyMPHA as a safe, effective, and underutilized method to improve survivorship outcomes.

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

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 ...

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. abs.amegroups.org abs.amegroups.org/article/view/6712/html

Immediate lymphatic reconstruction for breast cancer - Seth Early outcomes from using this technique have been promising, both in the literature and within our own institutions, demonstrating significant improvements in ...