Liposuction for Arm Lymphedema Following Breast Cancer Surgery
Liposuction for Arm Lymphedema Following Breast Cancer Surgery
ClinicalTrials.gov
This study is currently recruiting participants.
Verified by H. Lee Moffitt Cancer Center and Research Institute, July 2009
First Received: January 5, 2009 Last Updated: July 30, 2009 History of Changes
Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
Susan G. Komen Breast Cancer Foundation
Information provided by: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00816985
Purpose
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.
Condition Intervention Phase
Breast Cancer
Procedure: Liposuction
Phase II
Study Type: Interventional
Study Design: Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Liposuction for Arm Lymphedema Following Breast Cancer Surgery
Resource links provided by NLM:
Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome
MedlinePlus related topics: Breast Cancer Cancer Lymphedema Surgery
U.S. FDA Resources
Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:
Primary Outcome Measures:
* Investigate the safety and efficacy of liposuction to reduce arm lymphedema [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
* Assess the durability of lymphedema reduction over time [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 33
Study Start Date: June 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Procedure: Liposuction
We plan to show the efficacy of liposuction as a treatment for lymphedema. Durability will be tested for equivalence, by comparing the 3-month and 12-month arm volumes.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No
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.
* 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. AST(SGOT)/ALT(SGPT) ≤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.
* Can 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816985
Contacts
Contact: Christine Laronga, M.D. 813-745-4673 christine.laronga@moffitt.org
Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Christine Laronga, M.D. 813-745-4673 christine.laronga@moffitt.org
Principal Investigator: Christine Laronga, M.D.
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Christine Laronga, M.D. H. Lee Moffitt Cancer Center and Research Institute
More Information
Additional Information:
Moffitt Cancer Center Clinical Trials website This link exits the ClinicalTrials.gov site
No publications provided
Responsible Party: H.Lee Moffitt Cancer Center & Research Institute ( Christine Laronga, M.D. )
Study ID Numbers: MCC-14728, USF IRB 104892B
Study First Received: January 5, 2009
Last Updated: July 30, 2009
ClinicalTrials.gov Identifier: NCT00816985 History of Changes
Health Authority: United States: Institutional Review Board
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Female
Lymphedema
Study placed in the following topic categories:
Lymphedema
Lymphatic Diseases
Skin Diseases
Breast Neoplasms
Breast Diseases
Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases
ClinicalTrials.gov processed this record on September 04, 2009
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