A Single Center, Prospective Treatment Trial to Assess Prophylactic Use of Trental (Pentoxifylline) and Vitamin E to Prevent Capsular Contracture After Implant Reconstruction in Patients Requiring Adjuvant Radiation Therapy
Sponsor study identifier
interventional
30
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The main purpose of this research study is to determine if the use of Trental and Vitamin E will decrease the incidence and severity of contractures (shrinking and or hardening of tissue surrounding the implant) associated with breast implant reconstruction following radiation treatment. Another goal is to find out the impact that Trental and Vitamin E have on implant loss or need for surgical intervention in the setting of chest wall radiation after reconstruction. In addition, the investigators want to evaluate the patient's sense of well being and quality of life.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
March 4, 2010
Actual (reported)March 5, 2010
Actual (reported)August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Measure number and grade of contractures occurring after implant reconstruction and radiation treatment in subjects receiving Trental and vitamin E combination compared to placebo using the Bakers grade assessment
6 months
Number of implant revisions or loss of implants due to post radiation changes in subject receiving Trental and vitamin E compared to placebo through patient interview with research staff
6 months
Trental and Vitamin E for 6 months
Trental and Vitamin E for 6 months
Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210, United States
Nathalie Johnson, MD
Legacy Health System
30 participants (actual enrollment reported by the registry).
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 28, 2013
Record last verified: 2013-08
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Source: ClinicalTrials.gov.
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