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Completed

NCT Number: NCT01508221

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

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.

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Key information

Conditions

Brain Metastasis Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trental

Drug

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

Other names: Pentoxifylline

Vitamin E

Dietary Supplement

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

Primary outcomes

  1. Number of Participants With Symptomatic Radiation Necrosis

    Time frame: average 1 year

    Number of symptomatic death of healthy tissue caused by radiation therapy.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2012
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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