Expired Study
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Iowa City, Iowa 52242


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.

Study summary:

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.


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



Primary Contact:

Principal Investigator
Geraldine Jacobson, MD MPH
department of radiation oncology

Backup Contact:


Location Contact:

Iowa City, Iowa 52242
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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