Clinical trial 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
Official title: Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage III Breast Cancer AJCC v8
Breast Inflammatory Carcinoma
Locally Advanced Breast Carcinoma
Melanoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-08
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: Volumetric diagnosis of lymphedema
timeFrame: 18 months
measure: Incidence of lymphedema
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Mark Schaverien
role: PRINCIPAL_INVESTIGATOR
References: