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

NCT ID: NCT01508221

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-02-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Trental + Vitamin E

Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment

Group Type: EXPERIMENTAL

Trental

Intervention Type: DRUG

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

Vitamin E

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Trental

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

Intervention Type: DRUG

Vitamin E

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Pentoxifylline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Michelle Marcum

Director, University of Cincinnati Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald Warnick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BTC-W1

Identifier Type: -

Identifier Source: org_study_id