What side effects are associated with this type of intervention?

Common treatments for skin cancer, particularly those involving surgical interventions such as lymph node dissection, can lead to several side effects. These include lymphedema, which is a chronic condition characterized by swelling due to lymph fluid buildup, and can significantly impact physical, occupational, and social participation. Other potential side effects include infection, scarring, and reduced range of motion. Prophylactic LVA aims to mitigate the risk of lymphedema by improving lymphatic drainage through the creation of connections between lymphatic vessels and veins.

What prior FDA approvals exist?

The FDA has approved various treatments for skin cancer, including surgical interventions, targeted therapies, and immunotherapies. While specific FDA approvals for Prophylactic Lymphaticovenous Anastomosis (LVA) are not detailed, surgical management of skin cancer often involves procedures to remove tumors and manage lymphatic drainage. For instance, lymph node dissection is a common practice to prevent metastasis. Additionally, targeted therapies like vemurafenib and immunotherapies such as pembrolizumab have been approved for advanced melanoma, a type of skin cancer. These treatments aim to improve survival rates and manage disease progression.

What other types of research exist?

Promising alternatives to Prophylactic LVA for skin cancer patients include: 1) Vascularized Lymph Node Transfer (VLNT), which involves transferring lymph nodes to the affected area to restore lymphatic function. 2) Minimally Invasive Free Vascularized Omental Lymphatic Flap, which uses omental tissue to improve lymphatic drainage. 3) Double Vascularized Omentum Lymphatic Transplant (VOLT), which enhances lymphatic function by using omental tissue with dual blood supply. These methods have shown positive outcomes in clinical studies and are viable options for 2024.

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Procedure

Lymphatic Reconstruction to Prevent Lymphedema After Skin Cancer Surgery (LYMbR Trial)

Phase 3

Waitlist Available

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

Research Sponsored by Alberta Health Services, Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult persons (>18 years of age) undergoing axilla or groin lymphadenectomy as part of cutaneous malignancy management.

Be older than 18 years old

Must not have

Patients receiving a sentinel lymph node biopsy alone

Patients with a previous history of radiation therapy to the affected nodal basin or extremity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, generally such surgical procedures may include risks like infection at the site of surgery, blood clots, scarring, and possibly changes in sensation around the treated areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am only getting a sentinel lymph node biopsy.

Select...

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

Select...

I have untreated cancer spread to the skin or lymph vessels of my arms or legs.

Select...

I have post-thrombotic syndrome.

Select...

I have swelling in my limbs before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Presence or absence of lymphedema at 24 months post axillary or groin lymphadenectomy as assessed by limb volume over time.

Quality of life impact as measured by LYMQOL PROM

Secondary study objectives

Incidence of evidence of acute post-operative surgical complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prophylactic lymphaticovenous anastomosisExperimental Treatment1 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 anastomosisActive Control1 Intervention

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for skin cancer include surgical excision, radiation therapy, and targeted therapies. Surgical excision involves physically removing the cancerous tissue, which is effective for localized tumors. Radiation therapy uses high-energy rays to destroy cancer cells by damaging their DNA, preventing them from growing and dividing. Targeted therapies, such as inhibitors of specific molecular pathways, block the growth and spread of cancer by interfering with molecules involved in tumor growth and progression. For skin cancer patients, these treatments are crucial as they directly target and eliminate cancer cells, reducing the risk of metastasis and recurrence. Prophylactic Lymphaticovenous Anastomosis (LVA) is particularly relevant as it improves lymphatic drainage, potentially preventing lymphedema, a common complication after lymph node dissection in cancer treatment.

Microsurgical techniques in the treatment of breast cancer-related lymphedema: a systematic review of efficacy and patient outcomes.Leech therapy in flap salvage: Systematic review and practical recommendations.