Conditions: Fibrosis
Keywords: Breast Neoplasms Radiotherapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: Control for study - watchful waiting. arm 2: Combined treatment with Pentoxifylline and Vitamin E.

Interventions: intervention 1: Pentoxifylline intervention 2: Vitamin E
Intervention descriptions: intervention 1: Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy. intervention 2: Vitamin E (Over-the-counter) 400 I.U. once daily

Protocol document: