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Tracking Information | |||||
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First Received Date ICMJE | July 14, 2004 | ||||
Last Updated Date | May 9, 2009 | ||||
Start Date ICMJE | September 2003 | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00087815 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain | ||||
Official Title ICMJE | Complimentary Hyperbaric Oxygen for Brain Radionecrosis | ||||
Brief Summary | 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. |
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Detailed Description | 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.
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. |
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Study Phase | |||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Supportive Care, Randomized, Single Blind, Active Control | ||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 30 | ||||
Completion Date | June 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00087815 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | CDR0000510427, UCMC-02101007 | ||||
Study Sponsor ICMJE | Barrett Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | July 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |