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Preventing Lymphedema with Lymphovenous Bypass for Breast Cancer and Melanoma

This study is looking at a procedure called lymphovenous bypass (LVB) to see if it can prevent arm swelling (lymphedema) in patients with certain types of breast cancer or melanoma. Lymphedema can happen after underarm lymph node surgery. Usually, LVB is done after lymphedema has already developed. This trial is testing if doing LVB *before* underarm lymph node surgery can stop lymphedema from starting. You might be able to join if you are 18 or older and have inflammatory breast cancer, locally advanced non-inflammatory breast cancer, or melanoma. The study will measure how many people develop lymphedema 18 months after surgery to see if LVB is helpful. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 252 participants who will be randomly assigned to one of two groups. One group receives Indocyanine Green and undergoes lymphangiography and lymphovenous bypass, while the other group does not.
What's involved
If you are in Group I, you will receive Indocyanine Green intravenously and undergo lymphangiography, then have a lymphovenous bypass procedure at the same time as your axillary lymph node dissection. If you are in Group II, you will not receive these interventions. All participants will have follow-up visits at 2 weeks, and then at 6, 12, and 18 months.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up at 2 weeks, and then at 6, 12, and 18 months after completing the study procedures.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03941756

Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma

Recruiting
NAAges 18+InterventionalPrevention
M.D. Anderson Cancer Center
~252 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Indocyanine GreenLymphangiographyLymphovenous Bypass

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Volumetric diagnosis of lymphedema
Measured over 18 months
+1 more outcome measured

Conditions

Anatomic Stage III Breast Cancer AJCC v8
Breast Inflammatory Carcinoma
Locally Advanced Breast Carcinoma
Melanoma

Explore related trials

Breast CarcinomaMelanoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Mark Schaverien · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Mark Schaverien
[email protected]
832-499-6321
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients greater than or equal to 18 years of age.
Patients willing to participate.
Patients able to complete informed consent.
Patients will be eligible for inclusion if they fall into one for two groups:
Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy
Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group.

Exclusion

Patients taking anticoagulants within 7 days prior to surgery.
Patients that are known to be pregnant at the time of surgery.
Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
Patients with body mass index (BMI) greater than 50.0.

What this trial measures

  • Volumetric diagnosis of lymphedema18 months

    If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.

  • Incidence of lymphedema18 months

    Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.