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Recruiting 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

No phase Interventional Anatomic Stage III Breast Cancer AJCC v8 Breast Inflammatory Carcinoma Locally Advanced Breast Carcinoma Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indocyanine Green, Lymphangiography, Lymphovenous Bypass.
Who it may be relevant to
Registry conditions: Anatomic Stage III Breast Cancer AJCC v8, Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma, Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study

Overview

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.

Detailed description

PRIMARY OBJECTIVES:

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.

Interventions

  • Drug Indocyanine Green
    Given IV
  • Procedure Lymphangiography
    Undergo lymphangiography
  • Procedure Lymphovenous Bypass
    Undergo LVB

Primary outcome measures

  • Volumetric diagnosis of lymphedema [Time frame: 18 months]
  • Incidence of lymphedema [Time frame: 18 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT03941756 · 2018-0127 · NCI-2019-02320 · 2018-0127 · P30CA016672

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗