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Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380353
First Posted: June 27, 2011
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Northwestern University
  Purpose

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.


Condition Intervention Phase
Breast Cancer Drug: Diclofenac epolamine patch Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Test Uniformity of Transdermal Drug Delivery to the Breast Using Diclofenac Epolamine as a Model

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen [ Time Frame: 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:
  • Determine how the concentrations of the study patch is distributed in the breast. [ Time Frame: 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).


Estimated Enrollment: 25
Study Start Date: June 2011
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast Group
Diclofenac epolamine patch applied to the breast
Drug: 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].
Other Name: Flecto Patch
Experimental: Abdomen Group
Diclofenac epolamine patch applied to the abdomen
Drug: 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].
Other Name: Flecto Patch

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380353


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Seema Khan, MD Northwestern University
  More Information

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01380353     History of Changes
Other Study ID Numbers: NU 10B05
STU00042939 ( Other Identifier: Northwestern University eIRB )
First Submitted: June 22, 2011
First Posted: June 27, 2011
Last Update Posted: November 24, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Northwestern University:
Women undergoing total mastectomy
Breast cancer prevention

Additional relevant MeSH terms:
Diclofenac
Diclofenac hydroxyethylpyrrolidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action