Lymphatic Reconstruction to Prevent Lymphedema After Skin Cancer Surgery

(LYMbR Trial)

Overseen By Carmen Webb, MA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alberta Health Services, Calgary

Disqualifiers: Sentinel biopsy, Untreated disease, Lymphedema, Thrombotic syndrome, Pregnancy, Radiation history

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called prophylactic lymphaticovenous anastomosis, aimed at preventing lymphedema. Lymphedema is a painful swelling that can occur after lymph node surgery for skin cancer. The trial will compare two groups: one receiving the new procedure during surgery and one not. It targets adults planning to have lymph nodes removed from the armpit or groin due to skin cancer. For those concerned about lymphedema, especially after surgery, this trial could be a suitable option. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

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

What prior data suggests that prophylactic lymphaticovenous anastomosis is safe for preventing lymphedema?

Research has shown that prophylactic lymphaticovenous anastomosis (LVA) is being studied to prevent lymphedema, a swelling that can occur after skin cancer surgery. This technique has previously treated lymphedema, and recent studies suggest it might also prevent it. A 2018 review of several studies found that using LVA during surgery reduced the risk of developing lymphedema by about two-thirds.

Regarding safety, other studies indicate that prophylactic LVA does not increase the risk of cancer returning or spreading. Thus, adding LVA to the surgery does not make cancer recurrence or progression more likely. However, limited information exists on long-term safety, so ongoing research is crucial to fully understand the risks.

As this trial is in an advanced stage, some evidence suggests the treatment is generally safe. Prospective participants can feel somewhat reassured about the safety of prophylactic LVA but should also be aware that more long-term data is needed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about prophylactic lymphaticovenous anastomosis because it offers a new way to prevent lymphedema after skin cancer surgery. Unlike the standard lymphadenectomy procedure, which can lead to swelling and fluid buildup, this technique aims to reroute lymphatic fluid directly into the venous system. By creating a connection between the lymphatic and venous vessels, the treatment could significantly reduce the risk of lymphedema, a common and often debilitating side effect of lymph node removal. This innovative approach has the potential to improve the quality of life for patients undergoing cancer surgery.

What evidence suggests that prophylactic lymphaticovenous anastomosis is effective for preventing lymphedema after skin cancer surgery?

Research has shown that prophylactic lymphaticovenous anastomosis (LVA), a procedure participants in this trial may receive, can significantly reduce the risk of developing lymphedema after lymph node surgery. A review of studies found that this procedure reduced the risk of lymphedema by two-thirds. In simpler terms, two out of three people who might have developed lymphedema did not when they underwent this surgery. Earlier research with melanoma patients demonstrated that LVA effectively lowered the chances of lymphedema without affecting cancer treatment outcomes. These findings suggest that LVA could be a promising method to prevent lymphedema and improve quality of life after skin cancer surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Claire Temple-Oberle, MD, MSc, FRCSC, MMEd

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

Adults over 18 who are undergoing lymph node removal in the armpit or groin area due to skin cancer can join. It's not for those just getting a sentinel lymph node biopsy, with untreated limb disease, leg vein clots (post-thrombotic syndrome), pregnancy, prior radiation in the area, or pre-existing lymphedema.

Inclusion Criteria

I am an adult having lymph node removal in my armpit or groin for skin cancer treatment.

Exclusion Criteria

I have swelling in my limbs before surgery.

I have had radiation therapy on the area where my cancer's lymph nodes are located.

I am only getting a sentinel lymph node biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Prophylactic LVA

Participants undergo lymphadenectomy with or without prophylactic lymphaticovenous anastomosis

Immediate (at time of surgery)

1 visit (in-person)

Follow-up

Participants are monitored for lymphedema development and quality of life at 6-month intervals

24 months

5 visits (in-person) at 6-month intervals

Long-term Follow-up

Participants undergo radionuclide lymphoscintigraphy to assess lymphatic function

At 24 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prophylactic Lymphaticovenous Anastomosis

Trial Overview The trial is testing if doing a special procedure called prophylactic LVA during surgery for skin cancer can prevent swelling of limbs (lymphedema). Participants will be randomly placed into groups and followed up to see if they develop lymphedema and how their quality of life is affected.

How Is the Trial Designed?

Group I: Prophylactic lymphaticovenous anastomosis Experimental Treatment 1 Intervention

Intervention participants will undergo prophylactic lymphaticovenous anastomosis as an addendum to axillary or ilioinguinal lymphadenectomy for treatment of cutaneous malignancy.

Group II: Lymphadenectomy without lymphaticovenous anastomosis Active Control 1 Intervention

Control participants will undergo axillary or ilioinguinal lymphadenectomy without lymphaticovenous anastomosis for treatment of cutaneous malignancy .

Who Is Running the Clinical Trial?

Alberta Health Services, Calgary

Lead Sponsor

Trials

15

Recruited

2,600+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Tom Baker Cancer Centre

Collaborator

Trials

30

Recruited

8,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9015841/

Primary Prevention of Cancer-Related Lymphedema Using ... Several studies have proven prophylactic lymphovenous anastomosis (LVA) performed after lymphadenectomy can potentially reduce the risk of cancer-related ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05136079?intr=Immediate

Study Details | NCT05136079 | Prophylactic LYMphatic ... Trial Objective: To ascertain the efficacy and impact of prophylactic lymphaticovenous anastomosis for prevention of lymphedema in cutaneous malignancy ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.9557

Prophylactic lymphaticovenous bypass performed during ... Results: A total of 46 melanoma patients underwent prophylactic LVA during this time period. Twenty-three of these patients met all inclusion ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11895410/

A Systematic Review and Meta‐Analysis - PMC Clinical improvement of UEL was 29.44% (95% CI: 15.58–43.29) for LVA, 41.66% (95% CI: 34.13–49.20) for VLNT, and 32.80% (95% CI: 21.96–43.64) ...

5. link.springer.com link.springer.com/article/10.1245/s10434-022-12874-6

ASO Author Reflections: Prophylactic Lymphaticovenous ... The study showed no difference in melanoma-free survival or recurrence between the patients who underwent prophylactic LVA and those who received therapeutic ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36471187/

Prophylactic Lymphaticovenous Anastomosis Performed ... Conclusion: Prophylactic LVA performed for macrometastatic melanoma is not a strong risk factor for relapse and metastasis. Level of evidence: ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1015958422003517

Immediate inguinal lymphaticovenous anastomosis ... The data regarding the long-term efficacy and safety of this procedure was limited. Therefore, we evaluated the long-term outcomes of immediate LVA in patients ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/14/4/e086226

The N-LVA Study: effectiveness and cost ... The objective of this study is to evaluate whether LVA is effective and cost-effective compared with sham surgery in improving the HRQoL.