Women's Mammography Study To Improve Comfort During Mammography

• Sponsor: Kenneth A. Kist, (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01716052
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: placebo; Drug: Ibuprofen	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Measure of Discomfort of Mammography [3 years]

   The primary outcome measure will be the response to questions on a questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kenneth A. Kist,, Principal Investigator, The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT01716052
• Other Study ID Numbers: CTRC 11-45; HSC20120142H
• First Posted: Oct 29, 2012
• Last Update Posted: Dec 30, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Kenneth A. Kist,, Principal Investigator, The University of Texas Health Science Center at San Antonio: Mammogram; Ibuprofen; Pain management
• Additional relevant MeSH terms: Ibuprofen

Study Results

Participant Flow

Recruitment Details	When the woman signs in at the breast imaging clinic desk (on the 5th floor of the Zeller Building at the CTRC), she will be asked if she would speak with the study nurse about this study.

Arm/Group Title	Ibuprofen	Placebo
Arm/Group Description	Pfizer 200 mg caplets (Advil) Ibuprofen	Lactulose placebo: Lactulose
Period Title: Overall Study
STARTED	1	1
COMPLETED	0	0
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Ibuprofen	Placebo	Total
Arm/Group Description	Pfizer 200 mg caplets (Advil) Ibuprofen	Lactulose placebo: Lactulose	Total of all reporting groups
Overall Participants	1	1	2
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 100%	1 100%	2 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 100%	1 100%	2 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%	1 100%	2 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

No data was collected or analyzed for the outcome measure because the study was terminated.

Arm/Group Title	Ibuprofen	Placebo
Arm/Group Description	Pfizer 200 mg caplets (Advil) Ibuprofen	Lactulose placebo: Lactulose
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	Total number of participants at risk is "0" since adverse events were not collected/assessed.
Arm/Group Title	Ibuprofen		Placebo
Arm/Group Description	Pfizer 200 mg caplets (Advil) Ibuprofen		Lactulose placebo: Lactulose
All Cause Mortality
	Ibuprofen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ibuprofen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Ibuprofen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.