NCT01508221

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

A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Brain Metastasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-06-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2012-01-11
• Last updated: 2023-09-14
• Results posted: 2023-09-14

Locations

1 site across 1 country: United States