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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Subjective, Objective, Management, and Analytic (SOMA) Score
A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.
18 month post-treatment
Geraldine Jacobson, MD MPH
department of radiation oncology
United States: Institutional Review Board
|The University of Iowa Hospitals & Clinics||Iowa City, Iowa 52242|