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

NCT01508221 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-09-14

Study results available
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Summary

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.

Conditions

  • Brain Metastasis

Interventions

DRUG

Trental

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

DIETARY_SUPPLEMENT

Vitamin E

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

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Ronald Warnick, MD · University of Cincinnati

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2017-02-01
Completion
2017-02-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01508221 on ClinicalTrials.gov