Complementary Hyperbaric Oxygen for Brain Radionecrosis

补充高压氧治疗脑放射性坏死

• 批准号: 6676053
• 负责人: LAURIE BETH GESELL
• 金额: $ 23.03万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-02 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6676053
• 关键词: alternative medicine; angiogenesis; brain; brain edema; brain neoplasms; clinical research; combination therapy; disease /disorder prevention /control; human subject; human therapy evaluation; hyperbaric oxygen therapy; magnetic resonance imaging; necrosis; neoplasm /cancer chemotherapy; neoplasm /cancer radiation therapy; neuroprotectants; pathologic process; patient oriented research; perfusion; positron emission tomography; quality of life; questionnaires; steroids; therapy adverse effect

DESCRIPTION (provided by applicant): A fundamental challenge facing neuro-oncologists is how to ameliorate the morbidity and mortality occurring as a side effect of radiation. Brain radionecrosis, the most significant complication associated with radiation therapy for treating brain tumors, is a spectrum of disease from edema to tissue necrosis. In those it does not kill, it can be devastating with significant morbidity associated. There is no known treatment that can mitigate the injury for all patients. An alternative therapy is a fundamental necessity. We propose to demonstrate the utility and effectiveness of a complementary therapy: Hyperbaric Oxygen Therapy (HBOT). This alternative therapy may be a powerful means to ameliorate the devastating consequences of radionecrosis of the brain. HBOT is successfully used as an adjunctive treatment for radionecrosis in bone and soft tissue. By promoting angiogenesis, revascularization of the injured tissue is facilitated. We believe similar revascularization might occur in neural tissue but this is not proven. The main objectives of this project are to 1) obtain pilot data demonstrating the potential for increased benefit when complementing conventional steroid therapy with HBOT for brain radionecrosis patients, 2) estimate the magnitude of benefit of HBOT to brain radionecrosis patients using objective measures of neurologic function, radiographic imaging and standardized quality of life measures, and 3) obtain preliminary data of the effect of HBOT on cerebral revascularization using perfusion MRI. Our central hypothesis is that conventional care with complementary HBOT will result in decreased neurologic deficit, increased quality of life, and decreased progression or reversal of brain radionecrosis when compared to conventional care alone. We will randomize consenting patients to either steroid therapy or steroid therapy with HBOT. We will use standardized physical examinations, PET scans, MRI and health related quality of life questionnaires to evaluate outcomes. Outcomes will be measured at regular intervals during and after treatment. Perfusion MRI will be used to investigate the process of revascularization. We will use these results to appropriately design future studies to more fully evaluate the use of HBOT in brain radionecrosis. Demonstrating a reduction in neural injury and its sequelae by using HBOT has the potential to fill the void of successful treatments available to brain radionecrosis patients.

描述（由申请人提供）：神经肿瘤学家面临的一个基本挑战是如何改善辐射副作用引起的发病率和死亡率。脑放射性坏死是与治疗脑肿瘤的放射治疗相关的最重要的并发症，是从水肿到组织坏死的一系列疾病。对于那些它不杀死的人来说，它可能是毁灭性的，并伴随着显着的发病率。目前还没有已知的治疗方法可以减轻所有患者的损伤。替代疗法是根本必要的。我们建议证明补充疗法的实用性和有效性：高压氧疗法（HBOT）。这种替代疗法可能是减轻放射性脑坏死破坏性后果的有效手段。 HBOT 已成功用作骨和软组织放射性坏死的辅助治疗。通过促进血管生成，促进受损组织的血运重建。我们相信类似的血运重建可能会发生在神经组织中，但这尚未得到证实。该项目的主要目标是 1) 获得试点数据，证明 HBOT 补充常规类固醇治疗对脑放射性坏死患者有增加益处的潜力，2) 使用神经功能的客观测量来估计 HBOT 对脑放射性坏死患者的益处程度、放射成像和标准化生活质量测量，以及 3) 使用灌注 MRI 获得 HBOT 对脑血运重建效果的初步数据。我们的中心假设是，与单独的传统护理相比，补充 HBOT 的常规护理将减少神经功能缺损，提高生活质量，并减少脑放射性坏死的进展或逆转。我们会将同意的患者随机分为类固醇治疗或类固醇联合 HBOT 治疗。我们将使用标准化体检、PET 扫描、MRI 和健康相关生活质量问卷来评估结果。将在治疗期间和治疗后定期测量结果。灌注 MRI 将用于研究血运重建过程。我们将利用这些结果来适当设计未来的研究，以更全面地评估 HBOT 在脑放射性坏死中的应用。 HBOT 能够减少神经损伤及其后遗症，有可能填补脑放射性坏死患者成功治疗的空白。