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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03941756
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Indocyanine Green — DRUG
    Given IV
  • Lymphangiography — PROCEDURE
    Undergo lymphangiography
  • Lymphovenous Bypass — PROCEDURE
    Undergo LVB

Study Details

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.

Key Dates

Start date
Aug 14, 2018
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group I (LVB)
    Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
  • No Intervention: Group II (no intervention)
    Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.

Primary Outcome Measure

Volumetric diagnosis of lymphedema [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Mark Schaverien
[email protected]
832-499-6321
Sara Hull, BSN,MHA,RN
[email protected]
832-499-6321
Mark Schaverien (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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