For a review of studies in this field, skip down to PUBLISHED RESEARCH.

For studies currently in progress at the center, skip down to CURRENT RESEARCH.

For the anticipated impact of these studies, skip down to IMPACT OF RESEARCH.

The medical community has had little experience using hyperbaric oxygen therapy for treating brain radionecrosis, but limited case series have supported its use.

In 1993, Fontanesi et al. reported a positive outcome for a patient with brain radiation necrosis after treatment for a glioblastoma multiforme tumor using hyperbaric oxygen therapy.²⁵ This individual experienced clinical improvements and stabilization of previously worsening neuroimaging findings. One year later, Fontanesi reported outcomes on three patients.²⁶ All individuals had suffered from continued progression of injury while on high dose steroids. After completion of hyperbaric oxygen therapy, neuroimaging findings had resolved and performance had improved. In 1997, Chuba et al. reported their experience using hyperbaric oxygen therapy to treat ten children suffering from brain radionecrosis.¹¹ Patient ages ranged from four to twenty-three and all had experienced increasing neurological deficits, worsening neuroimaging findings, and failure of steroid control.

With hyperbaric oxygen therapy, initial stabilization or improvement on neuroimaging was observed for 90% of patients, while prolonged benefits were present for 60%. In 1998, Leber et al. reported

The National Cancer Institute is supporting researchers at the Brain Radionecrosis Center to compare standard medical management of brain radionecrosis to medical management combined with hyperbaric oxygen therapy in a randomized, controlled fashion.

Patients currently undergoing medical management with increasing steroid dosage are candidates for this trial. These patients would normally be treated with steroids until dosages become excessive and surgical alternatives would be considered if viable. The patients will be randomized either to:

     • Standard medical management with steroids

     • Standard medical management with steroids
       AND Hyperbaric Oxygen therapy

Once a patient has been enrolled, the Baseline examination will be performed including:

     1. MRI and/or PET scans

     2. Detailed Neurologic Assessment

     3. Measurement of Quality of Life

The patient's treatment regimen will be standardized according to our predefined protocol, and their anti-convulsant therapy will be optimized. They will then receive either: i) hyperbaric oxygen treatments and medical management, or ii) receive medical management alone. Throughout the study, our physicians will aggressively monitor patients. Routine examinations will be performed daily and/or weekly. Complete examinations, during which we will collect study data, will be performed at regularly scheduled intervals during treatments, immediately post-treatment, and at additional intervals following treatment. These examinations will include various radiological measures and physical exams as well as measures of quality of life. Throughout this project, the study physicians will maintain their position as the primary physician for coordination of care for the patient so that all outcomes and treatments can be satisfactorily monitored.

In addition to studying the effects of treatment, we will select several patients to conduct additional non-invasive imaging studies to quantify the amount of neovascularization that has taken place within the radiation-induced area of injury. The inclusion of this additional imaging in our study will provide essential information for understanding how hyperbaric oxygen therapy is working.

The long-term goal of researchers at the Brain Radionecrosis Center is to expand the evidence base for treatment of brain radionecrosis and improve outcomes for patients by increasing the understanding of the therapies and the mechanisms by which they work. The current project will culminate in a better understanding of the essential features of hyperbaric oxygen therapy in brain radionecrosis. The research is significant because it is anticipated that complementing conventional medical care with hyperbaric oxygen therapy will halt the progression and reverse the neural injury in

brain radionecrosis patients. Demonstrating a reduction in neural injury and its sequelae when complementing conventional steroid therapy with hyperbaric oxygen therapy has the potential to fill the void of successful treatment modalities available to brain radionecrosis patients. In particular, this research could provide a treatment option for patients with inoperable brain radionecrosis that are unresponsive to steroids; these individuals currently have no therapeutic options remaining and are left with a fatal progression of their disease.