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Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT01380353
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
17.4
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Diclofenac epolamine patch
 Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
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
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Nov 12, 2012
Actual Study Completion Date :
Nov 12, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Flecto Patch

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Seema Khan, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Northwestern University
    ClinicalTrials.gov Identifier:
    NCT01380353
    Other Study ID Numbers:
    • NU 10B05
    • STU00042939
    First Posted:
    Jun 27, 2011
    Last Update Posted:
    Feb 19, 2020
    Last Verified:
    Feb 1, 2020
    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:
    Breast Neoplasms
    Diclofenac
    Diclofenac hydroxyethylpyrrolidine

    Study Results

    No Results Posted as of Feb 19, 2020