NCT01082003

Prevention of Capsular Contracture Using Trental and Vitamin E

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Legacy Health System · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Capsular Contractures

Interventions

Type	Name	Description
DRUG	Trental	Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-08-01
• Completion: 2014-06-01
• First posted: 2010-03-05
• Last updated: 2013-08-28

Locations

1 site across 1 country: United States