CompletedPhase 2

Trental & Vitamin E for Radiation-Induced Fibrosis

United States54 participantsStarted 2003-02

Plain-language 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.

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Subjective, Objective, Management, and Analytic (SOMA) Score

Timeframe: 18 month post-treatment

Trial details

NCT IDNCT00583700

SponsorUniversity of Iowa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-05

Results submitted2012-10-18

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