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

Trial Summary

What is the purpose of this trial?

The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.

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.

What data supports the effectiveness of this treatment for preventing lymphedema in breast cancer patients?

Research indicates that immediate lymphatic reconstruction (ILR) can significantly reduce the risk of developing lymphedema in breast cancer patients undergoing axillary lymph node dissection, with some studies suggesting a decrease in risk to 6.6%. ^{1 2 3 4 5}

Is Immediate Lymphatic Reconstruction (ILR) safe for preventing lymphedema in breast cancer patients?

Immediate Lymphatic Reconstruction (ILR) is generally considered safe for preventing lymphedema in breast cancer patients, as it is a surgical technique aimed at reducing the risk of developing this condition. However, patients who receive additional treatments like radiotherapy may have an increased risk of lymphedema. ^{1 2 5 6 7}

How is the treatment Immediate Lymphatic Reconstruction (ILR) unique in preventing lymphedema in breast cancer patients?

Immediate Lymphatic Reconstruction (ILR) is unique because it is performed at the same time as axillary lymph node dissection (ALND) to proactively prevent lymphedema, reducing the risk of developing this condition to 6.6%, compared to the 30% risk without it. ^{1 2 4 8 9}

Research Team

Michelle Coriddi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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) 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Immediate Lymphatic Reconstruction to Prevent Breast Cancer-Related Lymphedema: A Systematic Review. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mitigating Breast-Cancer-Related Lymphedema-A Calgary Program for Immediate Lymphatic Reconstruction (ILR). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Immediate Lymphatic Reconstruction to Decrease Incidence of Breast Cancer-related Lymphedema: Preliminary Results of Randomized Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Establishment and Feasibility of an Immediate Lymphatic Reconstruction Program in a Community Health System. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Quantifying radiation in the axillary bed at the site of lymphedema surgical prevention. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

United States insurance coverage of immediate lymphatic reconstruction. [2023]

7. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Assessing the preventive effect of immediate lymphatic reconstruction on the upper extremity lymphedema. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Immediate Lymphatic Reconstruction for Prevention of Secondary Lymphedema: A Meta-Analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Immediate Lymphatic Reconstruction in Prevention of Breast Cancer-Related Lymphedema. [2023]