Surgical Technique for Preventing Lymphedema After Breast Cancer Surgery

Not currently recruiting at 1 trial location

Overseen By Sheri Ramaker, R.N.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Prior axillary dissection, radiation, lymphedema, others

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

Compensation: Varies

Number of Visits: 4

Duration: Surgery and immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special surgical technique can prevent lymphedema, a condition where excess fluid causes swelling, after breast cancer surgery. Researchers are testing whether axillary reverse mapping (ARM) and lympho-venous bypass (LVB) during axillary lymph node dissection (ALND) can help reduce swelling. Participants are divided into two groups: one will undergo surgery with ARM and LVB, while the other will have surgery without these techniques. This trial targets patients scheduled for lymph node removal who are at high risk for requiring this procedure during surgery. As an unphased trial, it offers patients the chance to contribute to innovative surgical techniques that could improve post-surgery outcomes.

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

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

What prior data suggests that this surgical technique is safe for preventing lymphedema after breast cancer surgery?

Research has shown that adding axillary reverse mapping (ARM) and lympho-venous bypass (LVB) to axillary lymph node dissection (ALND) is safe. Studies have found that ARM significantly reduces the risk of lymphedema, which is swelling caused by a build-up of lymph fluid, after breast cancer surgery. Notably, the chance of cancer spreading to lymph nodes identified by ARM remains low, indicating that this method does not compromise safety.

These techniques have been used together for several years, with evidence supporting their effectiveness in reducing lymphedema without introducing significant risks. This can reassure patients considering these procedures as part of their treatment plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new surgical technique aimed at preventing lymphedema after breast cancer surgery. Unlike standard procedures that involve axillary lymph node dissection (ALND) alone, this approach uses Axillary Reverse Mapping (ARM) combined with a lympho-venous bypass (LVB). ARM helps identify and preserve lymphatic channels, potentially reducing the risk of lymphedema. The addition of LVB further enhances this technique by rerouting lymphatic fluid directly into the venous system, offering a more comprehensive strategy to maintain normal lymphatic function. This combination could significantly improve post-surgical outcomes for breast cancer patients.

What evidence suggests that this surgical technique is effective for preventing lymphedema?

This trial will compare two surgical techniques for preventing lymphedema after breast cancer surgery. One group of participants will undergo Axillary Lymph Node Dissection (ALND) with Axillary Reverse Mapping (ARM) and possibly Lympho-venous Bypass (LVB). Research has shown that ARM with LVB during axillary lymph node removal can help prevent lymphedema. Studies have found that ARM can identify and protect the lymph vessels that drain fluid from the arm, reducing the risk of lymphedema. Specifically, patients who underwent ARM during their surgery experienced less swelling over time compared to those who did not. This method focuses on preserving important lymph nodes, maintaining normal fluid flow, and reducing swelling. Overall, ARM with LVB shows promise in reducing the chances of lymphedema after surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

James W Jakub

Principal Investigator

Mayo Clinic

Mara Piltin, DO

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for English-speaking patients at high risk of needing axillary lymph node dissection (ALND) as judged by their surgeon. It's not for those who've had radiation in the same armpit area, only need a sentinel lymph node biopsy, have been treated or are being treated to prevent arm lymphedema, or are pregnant.

Inclusion Criteria

My surgeon thinks I might need a more extensive lymph node surgery based on what is found during surgery.

I am scheduled for surgery to remove lymph nodes under my arm.

Exclusion Criteria

I am having a minor lymph node surgery or my doctor thinks it's unlikely I'll need a more extensive one.

I have been treated or am being treated to prevent swelling in my arm(s).

I have had radiation therapy on the same side as my underarm before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

All subjects undergo axillary lymph node dissection (ALND), with some receiving axillary reverse mapping (ARM) and lympho-venous bypass (LVB)

Surgery and immediate post-operative period

Follow-up

Participants are monitored for limb volume and symptoms of lymphedema at 6, 12, 24, and 36 months after surgery

36 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ALND
• ALND with ARM +/- LVB

Trial Overview The study aims to see if adding axillary reverse mapping (ARM) and lympho-venous bypass (LVB) when performing ALND can reduce the chances and severity of developing arm lymphedema after surgery in breast cancer and melanoma patients.

How Is the Trial Designed?

Group I: ALND with ARM +/- LVB Experimental Treatment 1 Intervention

Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.

Group II: ALND without ARM +/- LVB Active Control 1 Intervention

Axillary Lymph Node Dissection (ALND)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8102224/

The effectiveness of axillary reverse mapping in preventing ... ARM during ALND can prevent and reduce the occurrence of BCRL in patients with early-stage BC during long-term follow-up.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03927027

Study Details | NCT03927027 | Axillary Reverse Mapping ... This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node ...

3. pssjournal.biomedcentral.com pssjournal.biomedcentral.com/articles/10.1186/s13037-019-0217-1

Prevention of lymphedema via axillary reverse mapping for ... In the current study, our objectives were to assess the effectiveness of arm-node preservation by ARM for prevention of lymphedema in patients ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0960977620301600

Clinical application of axillary reverse mapping in patients ... The efficacy of arm node preserving surgery using axillary reverse mapping for preventing lymphedema in patients with breast cancer. Journal of Breast Cancer ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34498

Occurrence of breast‐cancer–related lymphedema after ... Axillary reverse mapping (ARM) can identify the lymphatics draining the arm, enabling the selective sparing of axillary lymph nodes to reduce ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7474002/

Clinical application of axillary reverse mapping in patients with ... ARM was found to significantly reduce the incidence of BCRL. The selection of patients for this procedure should be based on their axillary nodal status.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4354953/

Axillary Reverse Mapping: Five Year Experience - PMC Metastases in ARM-identified lymph nodes were acceptably low indicating that ARM is safe. ARM added to present-day ALND and SLNB may be useful to lower ...

8. 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 ...

9. southcarolinablues.com southcarolinablues.com/web/public/brands/medicalpolicyih/external-policies/axillary-reverse-mapping-for-breast-cancer-related-lymphedema/

Axillary Reverse Mapping for Breast Cancer-Related ... Axillary reverse mapping, also called reverse lymphatic mapping, has been developed with the intent of sparing axillary lymph nodes and lymphatics during breast ...