Lymphatic Reconstruction to Prevent Lymphedema After Skin Cancer Surgery

(LYMbR Trial)

Recruiting in Calgary (>99 mi)

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a surgical technique called prophylactic LVA to prevent swelling in patients having lymph nodes removed due to skin cancer. The procedure creates new drainage paths for lymph fluid to reduce the risk of lymphedema. The study aims to see if this technique improves patients' quality of life and reduces complications.

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 data supports the effectiveness of the treatment Prophylactic Lymphaticovenous Anastomosis in preventing lymphedema after skin cancer surgery?

Research shows that prophylactic lymphaticovenous anastomosis (LVA) can reduce the risk of lymphedema (swelling due to fluid buildup) after cancer-related surgeries. A systematic review found that LVA significantly decreased the incidence of lymphedema in both upper and lower limbs after lymph node removal, suggesting it may be effective in preventing lymphedema after skin cancer surgery as well. ^{1 2 3 4 5}

Is lymphaticovenous anastomosis (LVA) safe for preventing lymphedema after surgery?

Research shows that lymphaticovenous anastomosis (LVA) is generally safe, with studies reporting no early or late surgical complications in patients who underwent the procedure to prevent lymphedema after surgery and radiotherapy. ^{1 4 6 7 8}

How does the treatment Prophylactic Lymphaticovenous Anastomosis differ from other treatments for preventing lymphedema after skin cancer surgery?

Prophylactic Lymphaticovenous Anastomosis (LVA) is unique because it involves microsurgical techniques to connect lymphatic vessels to nearby veins immediately after lymph node removal, aiming to prevent lymphedema (swelling due to lymph fluid buildup) from developing. This approach is different from other treatments that typically address lymphedema after it has already occurred, rather than preventing it from the outset. ^{1 3 4 5 9}

Research Team

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

Principal Investigator

University of Calgary

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Immediate inguinal lymphaticovenous anastomosis following lymphadenectomy in skin cancer of lower extremities. [2022]

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

Reverse Lymphatic Mapping and Immediate Microsurgical Lymphatic Reconstruction Reduces Early Risk of Breast Cancer-Related Lymphedema. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Primary Prevention of Cancer-Related Lymphedema Using Preventive Lymphatic Surgery: Systematic Review and Meta-analysis. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Distally Prophylactic Lymphaticovenular Anastomoses after Axillary or Inguinal Complete Lymph Node Dissection Followed by Radiotherapy: A Case Series. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[TREATMENT OF POST-MASTECTOMY UPPER LIMB LYMPHEDEMA BY MODIFIED SIDE-TO-END LYMPHATICOVENULAR ANASTOMOSIS]. [2022]

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

Microsurgery for management of primary and secondary lymphedema. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Correlation between patency and clinical improvement after lymphaticovenous anastomosis (LVA) in breast cancer-related lymphedema: 12-month follow-up. [2022]

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

Prophylactic lymphaticovenous anastomoses for resection of soft tissue tumors of the thigh to prevent secondary lymphedema-a retrospective comparative cohort analysis. [2022]

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

Immediate Lymphatic Reconstruction: Technical Points and Literature Review. [2021]