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Women's Mammography Study To Improve Comfort During Mammography

This study is currently recruiting participants.
Verified January 2013 by The University of Texas Health Science Center at San Antonio
Sponsor:
Information provided by (Responsible Party):
Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01716052
First received: October 18, 2012
Last updated: January 5, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Pain
 Drug: placebo
Drug: Ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45

Resource links provided by NLM:

MedlinePlus related topics: Mammography
U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Measure of discomfort of mammography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The Primary outcome measure will be the response to question 1 of the post-mammogram questionnaire: 'How painful was today's mammogram?' [O-no hurt, 1-hurts a little bit, 2-hurts a little more, 3-hurts even more, 4-hurts a whole lot, 5-hurts worst]. The response to question 2, 'Was the amount of pain you experienced something that might make you reluctant to return for your next mammogram?' [yes, no] will be of secondary interest. The response to question 5 of the pre-mammogram questionnaire: 'How painful do you expect today's mammogram to be?' [O-no hurt, 1-hurts a little bit, 2-hurts a little more, 3-hurts even more, 4-hurts a whole lot, 5-hurts worst] will be used for statistical adjustment and to compute a change score as described in the protocol.


Estimated Enrollment: 187
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ibuprofen
Pfizer 200 mg caplets (Advil)
 Drug: Ibuprofen
Placebo Comparator: Placebo
Lactulose
 Drug: placebo
Lactulose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716052

Contacts
Contact: Epp Goodwin 210-450-5798 onctrial@idd.org

Locations
United States, Texas
Cancer Therapy and Research Center at UTHSCSA Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Kenneth Kist, MD            
Sponsors and Collaborators
Kenneth A. Kist,
Investigators
Principal Investigator: Kenneth Kist, MD University of Texas
  More Information

No publications provided

Responsible Party: Kenneth A. Kist,, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01716052     History of Changes
Other Study ID Numbers: CTRC 11-45, HSC20120142H
Study First Received: October 18, 2012
Last Updated: January 5, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Mammogram
Ibuprofen
Pain management

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013