Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment diclofenac epolamine patch
Phase phase 0
Sponsor Northwestern University
Start date June 2011
End date July 2017
Trial size 25 participants
Trial identifier NCT01380353, NU 10B05, STU00042939

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Diclofenac epolamine patch applied to the breast
diclofenac epolamine patch Flecto Patch
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].
(Experimental)
Diclofenac epolamine patch applied to the abdomen
diclofenac epolamine patch Flecto Patch
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].

Primary Outcomes

Measure
Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen
time frame: after 3 days of treatment prior to surgery

Secondary Outcomes

Measure
Determine how the concentrations of the study patch is distributed in the breast.
time frame: after three days of treatment prior to surgery

Eligibility Criteria

Female participants from 18 years up to 80 years old.

Inclusion Criteria: - Women between the ages of 18 and 80 years, undergoing total mastectomy for, with or without axillary surgery for diagnosis or prevention of breast cancer. - ECOG performance status less than 2. - Ability to understand and the willingness to sign a written informed consent. - Participants must have normal organ and marrow function Exclusion Criteria: - Prior history of ipsilateral breast radiotherapy. - Pregnant women and those who will be actively breast-feeding in the preoperative period will be excluded. - Inability to discontinue aspirin or warfarin use during the period of participation. - Known allergy to diclofenac epolamine, or aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID). - Renal failure

Additional Information

Official title Pilot Study to Test Uniformity of Transdermal Drug Delivery to the Breast Using Diclofenac Epolamine as a Model
Principal investigator Seema Khan, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Northwestern University.