The purpose of this study is to look for ways to improve breast cancer treatment by giving breast cancer drugs through the skin of the breast. The drug used in this study is a diclofenac epolamine patch and is a nonsteroid anti-inflammatory pain reliever. The drug amount that gathers in the breast, after application of a patch to the skin of the breast, will be measured and compared to the amount that is found in the breast when the patch is applied to the skin of the belly.
This is a randomized study where participants in group 1 will apply the diclofenac epolamine patch to the breast and participants in group 2 will apply the same drug to her abdomen. Participants are instructed to apply a new patch every 12 hours for 3 days. Total participation in this study will be for three days, ending on the day of surgery. On the day of surgery, participants will have blood drawn to measure the level of diclofenac epolamine in the body, and the final patch will be removed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patch (10cm X 14cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner \[B\].
Northwestern University
Chicago, Illinois, United States
Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen
The primary objective of this protocol will demonstrate that diclofenac epolamine patch applied to the skin of the breast for three days (1, 2) prior to surgery will result in significantly higher drug concentrations in the breast than the same dose applied to the abdominal skin for the same duration of time.
Time frame: after 3 days of treatment prior to surgery
Determine how the concentrations of the study patch is distributed in the breast.
To establish that the diclofenac epolamine drug concentrations achieved in the breast have no significant fall-off with increasing distance from the site of application. Therefore, uniform therapeutic concentrations are achieved throughout the breast with a single site of local transdermal therapy (LTT).
Time frame: after three days of treatment prior to surgery
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