Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis

University of Cincinnati31 enrolled

Overview

The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.

The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Brain Metastasis

Interventions

TrentalDRUG

400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months

Vitamin EDIETARY_SUPPLEMENT

400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor * Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer * Age \> 18 years * Partial or total resection of a metastatic tumor are eligible Exclusion Criteria: * Known sensitivity to vitamin E or Trental * Recent intracranial bleed or retinal hemorrhage * Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment * History of Avastin treatment * Anticipated need for treatment with Avastin * History of bleeding disorder * History of liver disorder

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Number of Participants With Symptomatic Radiation Necrosis

Number of symptomatic death of healthy tissue caused by radiation therapy.

Time frame: average 1 year

Data from ClinicalTrials.gov

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