Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

NCT ID: NCT01380353

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-11-12

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Breast Group

Diclofenac epolamine patch applied to the breast

Group Type: EXPERIMENTAL

Diclofenac epolamine patch

Intervention Type: DRUG

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 \[B\].

Abdomen Group

Diclofenac epolamine patch applied to the abdomen

Group Type: EXPERIMENTAL

Diclofenac epolamine patch

Intervention Type: DRUG

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 \[B\].

Interventions

Diclofenac epolamine 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 \[B\].

Intervention Type: DRUG

Other Intervention Names

Flecto Patch

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seema Khan, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00042939

Identifier Type: OTHER

Identifier Source: secondary_id

NU 10B05

Identifier Type: -

Identifier Source: org_study_id