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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
7
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.
Ratings of 0 to 4, with 0 being Not at ll and 4 being Very Much, regarding how true each statement has been. Statements are in the following categories: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Additional Concerns.
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Number of Participants With Desired Response
Investigators plan to show the efficacy of liposuction as a treatment for lymphedema. Investigators 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.
Time frame: 3 months post last off treatment date
Number of Participants With Durable Response
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.
Time frame: Post follow-up period - up to 5 years post treatment
Number of Participants Who Develop an Infection
Measures to reduce skin infections will be implemented in this study but observance of infections will be an important study endpoint.
Time frame: 12 months per participant
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