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Sponsors and Collaborators: |
Barrett Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00087815 |
RATIONALE: Hyperbaric oxygen may increase blood flow and decrease swelling in areas of the brain damaged by radiation therapy. Giving hyperbaric oxygen therapy together with dexamethasone may be an effective treatment for radiation necrosis of the brain.
PURPOSE: This randomized clinical trial is studying how well hyperbaric oxygen therapy works in treating patients with radiation necrosis of the brain.
Condition | Intervention |
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Brain and Central Nervous System Tumors Cancer-Related Problem/Condition |
Drug: dexamethasone Drug: hyperbaric oxygen Procedure: cognitive assessment Procedure: magnetic resonance imaging Procedure: positron emission tomography Procedure: quality-of-life assessment |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Single Blind, Active Control |
Official Title: | Complimentary Hyperbaric Oxygen for Brain Radionecrosis |
Estimated Enrollment: | 30 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | June 2005 |
OBJECTIVES:
OUTLINE: This is a pilot, randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
NOTE: *Patients in arm II who reach the maximum daily dose of dexamethasone are not removed from the study.
Patients are evaluated during study by standardized physical examinations, positron emission tomography scans, perfusion MRI, complete neurologic assessment, and standardized, health-related quality of life measures at baseline, at 30-day intervals during treatment, at the end of treatment, and at 1, 2, and 4 months after completion of study therapy.
After completion of study therapy, patients are followed at 1, 2, and 4 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Definitive diagnosis of brain radionecrosis by MRI and positron emission tomography scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
University of Cincinnati Medical Center | |
Cincinnati, Ohio, United States, 45267-0769 |
Principal Investigator: | Laurie Gesell, MD | Barrett Cancer Center |
Study ID Numbers: | CDR0000510427, UCMC-02101007 |
Study First Received: | July 14, 2004 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00087815 |
Health Authority: | United States: Federal Government |
cognitive/functional effects radiation toxicity adult brain tumor childhood brain tumor |
Dexamethasone Brain Neoplasms Necrosis |
Central Nervous System Neoplasms Dexamethasone acetate Nervous System Neoplasms |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Glucocorticoids |
Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |