Liposuction for Arm Lymphedema Following Breast Cancer Surgery
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Liposuction for Arm Lymphedema Following Breast Cancer Surgery|
- Number of Participants With Desired Response [ Time Frame: 3 months per participant ] [ Designated as safety issue: No ]We plan to show the efficacy of liposuction as a treatment for lymphedema. We will contrast the arm volume at 3 months with the baseline value using a paired t-test. Because the change in volume is likely to be proportional to the baseline value, the logarithm of the volumes will be used. With α = .05 and n = 34, we will have 80% power to detect an effect size of 0.5 (that is, a change of 0.5 standard deviations between the baseline and 3-month mean volumes). However since this is a pilot study with limited funding the study will initially open for 7 patients to assess safety and feasibility.
- Number of Participants With Durable Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]Durability will be tested for equivalence, by comparing the 3-month and 12-month arm volumes. Five year follow-up is necessary to demonstrate the lasting effect of liposuction in reducing arm lymphedema.
- Number of Participants Who Develop an Infection [ Time Frame: 12 months per participant ] [ Designated as safety issue: Yes ]Measures to reduce skin infections will be implemented in this study but observance of infections will be an important study endpoint.
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Liposuction is a procedure that involves the removal of fat from deposits beneath the skin using a hollow stainless steel tube with the assistance of a powerful vacuum. Liposuction can be accomplished either with the use of local or general anesthesia.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816985
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Christine Laronga, M.D.||H. Lee Moffitt Cancer Center and Research Institute|