Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

Early Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Diclofenac epolamine patch

• Registration Number: NCT01380353
• Lead Sponsor: Northwestern University

Brief 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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Primary Completion: 2012-11-12
• Study Completion: 2012-11-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast Group	Diclofenac epolamine patch	Diclofenac epolamine patch applied to the breast
Abdomen Group	Diclofenac epolamine patch	Diclofenac epolamine patch applied to the abdomen

Primary Outcome Measures

Name	Time	Method
Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen	after 3 days of treatment prior to surgery	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.

Secondary Outcome Measures

Name	Time	Method
Determine how the concentrations of the study patch is distributed in the breast.	after three days of treatment prior to surgery	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).

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States