- Patient selection involves identifying women who have undergone breast cancer surgery
in the past and who demonstrate lymphedema (stage 2 or 3) based on arm measurement at
a minimum of 4 different points along the affected arm. Those women with mild to
severe lymphedema with no signs of active infection are candidates for the procedure.
History of previous non-surgical treatment for lymphedema will not preclude entry
into this trial. All patients must be free of active disease recurrence at study
entry. If the lymphedema is of recent onset, then the womans medical oncologist or
primary care physician must rule out an underlying cancer recurrence or blood clot.
- Prior therapy including Manuel Lymph Drainage (MLD) or similar massage method, use of
compression sleeves, and pneumatic pumps is allowable and may be on-going at study
entry. Prior surgical procedures to treat lymphedema such a joining the lymph
channels to the blood vessels at any prior time are not eligible for this study.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%.
- Life expectancy of greater than one year
- Patients must have normal organ and marrow function as defined below:
1. leukocytes ≥3,000/MicroL
2. absolute neutrophil count ≥1,500/MicroL
3. platelets ≥100,000/MicroL
4. total bilirubin within normal institutional limits
5. aspartic transaminase(AST)/alanine transaminase(ALT) ≤2.5 X institutional upper
limit of normal
6. creatinine within normal institutional limits - OR - creatinine clearance ≥60
mL/min/1.73 m² for patients with creatinine levels above institutional normal.
- Able to tolerate general anesthesia and have no recent cardiac history such as
myocardial infarction, congestive heart failure, atrial fibrillation, or angina
- Ability to understand and the willingness to sign a written informed consent document
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents.
- Patients with known metastases should be excluded from this clinical trial because of
their poor prognosis.
- History of allergic reactions to compression sleeves, lymphedema bandages, general
anesthetics, and all antibiotics
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
- Pregnant women are excluded from this study because: General Anesthesia and/or
invasive surgical procedures may increase the risk of miscarriage. Secondly,
increased weight during pregnancy may exacerbate lymphedema and thereby make
interpretation of the study endpoints difficult.
- Patients with immune deficiency are at increased risk of lethal infections when
treated with invasive surgical procedures. Secondly, since this is an elective
procedure, the risk to the surgical team of a needle stick would be too high.