Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
NCT ID: NCT03941756
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
252 participants
INTERVENTIONAL
2018-08-14
2025-12-31
Brief Summary
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Detailed Description
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I. To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.
SECONDARY OBJECTIVES:
I. Compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.
GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group I (LVB)
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
Indocyanine Green
Given IV
Lymphangiography
Undergo lymphangiography
Lymphovenous Bypass
Undergo LVB
Group II (no intervention)
Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
No interventions assigned to this group
Interventions
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Indocyanine Green
Given IV
Lymphangiography
Undergo lymphangiography
Lymphovenous Bypass
Undergo LVB
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mark Schaverien
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Facility Contacts
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Mark Schaverien
Role: primary
Sara Hull, BSN,MHA,RN
Role: backup
Other Identifiers
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NCI-2019-02320
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0127
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0127
Identifier Type: -
Identifier Source: org_study_id