Women's Mammography Study To Improve Comfort During Mammography

Not Applicable

Terminated

• Conditions: Pain
• Interventions: Drug: Ibuprofen; Drug: placebo

• Registration Number: NCT01716052
• Lead Sponsor: Kenneth A. Kist,

Brief Summary

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.

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-29
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2015-01-13
• Results First Submitted QC: 2015-01-13
• Results First Posted: 2015-01-19
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen	Pfizer 200 mg caplets (Advil)
Placebo	placebo	Lactulose

Primary Outcome Measures

Name	Time	Method
Measure of Discomfort of Mammography	3 years	The primary outcome measure will be the response to questions on a questionnaire.

Trial Locations

Locations (1)

Cancer Therapy and Research Center at UTHSCSA; 🇺🇸 San Antonio, Texas, United States