Trental & Vitamin E for Radiation-Induced Fibrosis

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Treatments: alpha-Tocopherol; Pentoxifylline; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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:

• Cognitively impaired patients

• Prisoners

• No histology available

• Documented metastatic disease

• Allergy to Trental

• Life expectance of less than 12 months.

• Aged less than 20 years

• Collagen vascular disease present

• Pregnant

• History of liver disease

• Use of anticoagulants