Liposuction for Arm Lymphedema Following Breast Cancer Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00816985|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2009
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Liposuction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Liposuction for Arm Lymphedema Following Breast Cancer Surgery|
|Actual Study Start Date :||June 10, 2008|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2019|
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.
- Number of Participants With Desired Response [ Time Frame: 3 months per participant ]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 ]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 ]Measures to reduce skin infections will be implemented in this study but observance of infections will be an important study endpoint.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|