Women's Mammography Study To Improve Comfort During Mammography

December 1, 2015 updated by: Kenneth A. Kist,

Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45

The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center at UTHSCSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Must have signed the informed consent.
  • Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain

Exclusion Criteria:

  • May not have taken ibuprofen or other pain medication within the last 12 hours.
  • Must not have a contraindication for taking ibuprofen e.g:
  • No history of allergic reactions to ibuprofen or aspirin
  • No recent history with the last year of bleeding from GI tract
  • Not pregnant or suspected of being pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ibuprofen
Pfizer 200 mg caplets (Advil)
Drug: Ibuprofen
Placebo Comparator: Placebo
Lactulose
Drug: placebo
Lactulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Discomfort of Mammography
Time Frame: 3 years
The primary outcome measure will be the response to questions on a questionnaire.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenneth A. Kist,

Investigators

  • Principal Investigator: Kenneth Kist, MD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRC 11-45
  • HSC20120142H (Other Identifier: UTHSCSA IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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