About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients greater than or equal to 18 years of age.
Patients willing to participate.
Patients able to complete informed consent.
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Indocyanine Green
DrugGiven IV
Lymphangiography
Procedure/SurgeryUndergo lymphangiography
Lymphovenous Bypass
Procedure/SurgeryUndergo LVB
Treatment groups
Trial outcomes
Primary outcomes
Volumetric diagnosis of lymphedema
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
Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator