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NCT01508221 Clinical Trial

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

Brain Metastasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01508221
Other study ID # BTC-W1
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2011
Est. completion date February 1, 2017

Study information
Verified date August 2023
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date February 1, 2017
Est. primary completion date February 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of Cincinnati Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Symptomatic Radiation Necrosis Number of symptomatic death of healthy tissue caused by radiation therapy. average 1 year
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