Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
- Conditions
- Breast Inflammatory CarcinomaAnatomic Stage III Breast Cancer AJCC v8Locally Advanced Breast CarcinomaMelanoma
- Interventions
- Registration Number
- NCT03941756
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 252
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I (LVB) Lymphangiography Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND. Group I (LVB) Lymphovenous Bypass Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND. Group I (LVB) Indocyanine Green Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
- Primary Outcome Measures
Name Time Method Volumetric diagnosis of lymphedema 18 months 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.
Incidence of lymphedema 18 months Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States