Back to resultsEvaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis
Primary Purpose
Brain Metastasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trental
Vitamin E
Sponsored by
About this trial
This is an interventional prevention trial for Brain Metastasis focused on measuring brain metastasis
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
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trental + Vitamin E
Arm Description
Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
Outcomes
Primary Outcome Measures
Number of Participants With Symptomatic Radiation Necrosis
Number of symptomatic death of healthy tissue caused by radiation therapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT01508221
First Posted
January 8, 2012
Last Updated
August 22, 2023
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01508221
Brief Title
Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis
Official Title
A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastasis
Keywords
brain metastasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trental + Vitamin E
Arm Type
Experimental
Arm Description
Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
Intervention Type
Drug
Intervention Name(s)
Trental
Other Intervention Name(s)
Pentoxifylline
Intervention Description
400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Intervention Description
400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
Primary Outcome Measure Information:
Title
Number of Participants With Symptomatic Radiation Necrosis
Description
Number of symptomatic death of healthy tissue caused by radiation therapy.
Time Frame
average 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Warnick, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis
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