Women's Mammography Study To Improve Comfort During Mammography

This study has been terminated.
(Lack of funding.)
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: July 16, 2013
Last verified: July 2013
  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:


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.


Enrollment: 2
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
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: July 16, 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 July 28, 2014