[abstract] A RANDOMIZED, CONTROLLED TRIAL OF HYPERBARIC OXYGEN THERAPY FOR BRAIN RADIONECROSIS

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[abstract] A RANDOMIZED, CONTROLLED TRIAL OF HYPERBARIC OXYGEN THERAPY FOR BRAIN RADIONECROSIS

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Title: [abstract] A RANDOMIZED, CONTROLLED TRIAL OF HYPERBARIC OXYGEN THERAPY FOR BRAIN RADIONECROSIS
Author: Gesell, LB; Warnick, RE; Breneman, JC; Vogt, CJ; Lindsell, CJ
Abstract: BACKGROUND: Brain radionecrosis is a complication of brain radiation therapy, with significant morbidity and mortality associated. Non-invasive care relies on steroids; this is not always successful and is itself associated with complications. There are no other proven options. Hyperbaric oxygen therapy (HBOT) is successfully used for radiation necrosis in bone/soft tissue. We report on the design of a randomized, controlled clinical trial to test the efficacy of HBOT in ameliorating brain radionecrosis. MATERIALS AND METHODS: A research nurse screens patients referred for HBOT. Individuals undergo neuroimaging and structured examination by a study physician. Patients with PET confirmed brain radionecrosis, who have stable or worsening disease, and a steroid dose that cannot be tapered are eligible. Consenting patients are randomized to steroid management alone, or to steroid management with HBOT. For both study arms, steroid management is standardized for 3-months; dosing adjustments are made according to changes in edema volume and Karnofsky Performance Scores. Patients randomized to HBOT undergo 60 treatments over 3-months using an accelerated air-break protocol designed for brain radionecrosis patients. All patients undergo weekly structured examination. Detailed data (physical exam, subjective assessments, quality of life, neuropsychological testing, neuroimaging) are collected monthly during the active phase, and then at 1 month, 2 months, and 4 months for follow up. One third of patients receive vascular studies at baseline and end of treatment phase. RESULTS: Of 7 patients enrolled, 5 have had at least one adverse event, predominantly related to underlying disease. There have been no events related to HBOT and 2 related to steroid use (cellulitis). CONCLUSIONS: This trial is designed to demonstrate feasibility, safety and benefit of HBOT for brain radionecrosis. The severe nature of the disease and extensive comorbidities are challenging in conducting the trial. As patients health deteriorates, facilitating treatments, examinations and follow up is proving problematic.
Description: Undersea and Hyperbaric Medical Society, Inc. (http://www.uhms.org )
URI: http://archive.rubicon-foundation.org/1762
Date: 2005

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  • UHMS Meeting Abstracts
    This is a collection of the published abstracts from the Undersea and Hyperbaric Medical Society (UHMS) annual meetings.

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