Trental & Vitamin E for Radiation-Induced Fibrosis

University of Iowa

Status and phase

Completed

Phase 2

Conditions

Fibrosis

Treatments

Drug: Vitamin E

Drug: Pentoxifylline

Study type

Interventional

Funder types

Other

Identifiers

NCT00583700

200211003

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
No evidence of metastatic disease.
Minimum life expectancy of at least 12 months.
Aged greater than 20 years.
If female, pregnancy excluded.
No documented history of collagen vascular disease.

Exclusion criteria