Trial Information

Complimentary Hyperbaric Oxygen for Brain Radionecrosis

OBJECTIVES:

- Obtain pilot data demonstrating the potential for increased benefit when complementing
conventional steroid therapy with adjunctive hyperbaric oxygen therapy (HBOT) in
patients with brain radionecrosis.

- Estimate the magnitude of benefit of HBOT using objective measures of neurologic
function, radiographic imaging, and standardized quality of life measures in these
patients.

- Determine, preliminarily, the effect of HBOT on cerebral revascularization using
perfusion MRI in these patients.

- Determine the feasibility of performing a large-scale, randomized, controlled study
(particularly with regard to patient recruitment and retention) comparing HBOT with
conventional steroid therapy.

OUTLINE: This is a pilot, randomized, controlled study. Patients are randomized to 1 of 2
treatment arms.

- Arm I (conventional care only): Patients receive baseline steroid therapy comprising
oral dexamethasone 4 times daily. Steroid doses are either increased or decreased per
standard protocol during the 90-day treatment period. Patients who demonstrate
neurological deterioration at each evaluation (as evidenced by a decrease in Karnofsky
performance status score) receive escalating doses of dexamethasone until the maximum
daily dose of 32 mg is reached. Patients who reach the maximum daily dose of
dexamethasone are removed from the study. Patients also receive anticonvulsant therapy
during study therapy.

- Arm II (conventional care and hyperbaric oxygen therapy [HBOT]): Patients receive
conventional care as in arm I*. Patients also undergo HBOT once daily, 5 days a week,
for 90 days (60 treatments total).

NOTE: *Patients in arm II who reach the maximum daily dose of dexamethasone are not removed
from the study.

- Cerebral revascularization study: Five patients from each arm are randomly selected to
undergo perfusion MRI before treatment and within 1 week after completion of study
therapy to determine the proportion of cerebral neovascularization in each arm.

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.