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Pilot Study to Test Uniformity of Transdermal Drug Delivery to the Breast Using Diclofenac Epolamine as a Model


Phase 0
18 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Pilot Study to Test Uniformity of Transdermal Drug Delivery to the Breast Using Diclofenac Epolamine as a Model


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen

Outcome Description:

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.

Outcome Time Frame:

after 3 days of treatment prior to surgery

Safety Issue:

Yes

Principal Investigator

Seema Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

NU 10B05

NCT ID:

NCT01380353

Start Date:

June 2011

Completion Date:

July 2016

Related Keywords:

  • Breast Cancer
  • Women undergoing total mastectomy
  • Breast cancer prevention
  • Breast Neoplasms

Name

Location
Northwestern University Chicago, Illinois  60611