An interventional study of Trental in Capsular Contractures, sponsored by Legacy Health System. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-28.
Sponsored by Legacy Health System · Not applicable, Interventional, and Prevention
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.
This is a single center, 18-month study in which 30 women will receive Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months. Subjects will begin the treatment regimen within four weeks after completion of radiation treatment and will remain on the study drugs for six months. Following completion of active treatment, all subjects will enter the twelve-month observational phase of the trial in which they will be evaluated for changes in breast tissue using the following objective tools: Bakers Grade Assessment, Visual Analog Scale (VAS), implant revision or loss, breast photographs, adverse event assessment and the Quality of Life tool (SF-12).
151 studies on the registry are indexed under Contracture; 21 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 110 interventional studies indexed under Contracture.
Browse Contracture studies →Legacy Health System is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Trental and Vitamin E for 6 months
Drug: Trental
Trental and Vitamin E for 6 months
Drug: Trental
Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.
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
Time frame: 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
Time frame: 6 months
This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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