Trial Information

Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study

Radiation fibrosis occurs in approximately 25% of those women treated with radiation for
breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of
fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form
can cause pain in the breast, significant hardening, and inflammation.

Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen
therapy. The combination of Trental & Vitamin E has been used with success in Europe and at
the University of Iowa.

The focus of this study is to prevent fibrosis through intervention with Trental & Vitamin
E. The study has two arms, a control arm and an intervention arm. The study is not blinded.
Measurements are taken at standard follow-up visits to measure breast density and
lymphedema.