Trental & Vitamin E for Radiation-Induced Fibrosis

Fibrosis Clinical Trial

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

Status Completed

Clinical Trial Summary

This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fibrosis

• NCT number: NCT00583700
• Study type: Interventional
• Source: University of Iowa
• Status: Completed
• Phase: Phase 2
• Start date: February 2003
• Completion date: June 2012