Clinical trial · Interventional
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
NCT01508221CI-TRIAL-00069622completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasis | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trental | Drug | — | UNRESOLVED |
| Vitamin E | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trental + Vitamin E
- description
- Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
- interventionNames
- Drug: Trental
- Dietary Supplement: Vitamin E
Primary outcomes (1)
- measure
- Number of Participants With Symptomatic Radiation Necrosis
- timeFrame
- average 1 year
- description
- Number of symptomatic death of healthy tissue caused by radiation therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.