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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients greater than or equal to 18 years of age.

Patients willing to participate.

Patients able to complete informed consent.

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Indocyanine Green

    Drug

    Given IV

  • Lymphangiography

    Procedure/Surgery

    Undergo lymphangiography

  • Lymphovenous Bypass

    Procedure/Surgery

    Undergo LVB

Treatment groups

252 Participants
are divided into 2 treatment groups
Group A: Group I (LVB)Experimental treatment 3 interventions
Group B: Group II (no intervention)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Volumetric diagnosis of lymphedema

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.

Time frame
18 months
2

Incidence of lymphedema

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

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator