Clinical trial NCT00816985: Liposuction for Arm Lymphedema Following Breast Cancer Surgery
Official title: Liposuction for Arm Lymphedema Following Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Female
Lymphedema
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2009-01-06
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if a less invasive procedure such as liposuction can be used to effectively reduce arm lymphedema (swelling of the arm) resulting from breast cancer treatment. The standard surgery involves the removal of large portions of skin and tissue leaving a large scar. This less invasive procedure (liposuction) uses 3 to 4 tiny puncture sites and a vacuum tube leaving minimal scars.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 study requirements
* 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.

Primary outcomes:
measure: Number of Participants With Desired Response
timeFrame: 3 months post last off treatment date
Secondary outcomes:
measure: Number of Participants With Durable Response
timeFrame: Post follow-up period - up to 5 years post treatment
measure: Number of Participants Who Develop an Infection
timeFrame: 12 months per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Christine Laronga, M.D.
role: PRINCIPAL_INVESTIGATOR
References: