Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain

Sponsor

Barrett Cancer Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00087815

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Cognitive/Functional Effects Radiation Toxicity	Drug: dexamethasone Drug: hyperbaric oxygen Procedure: cognitive assessment Procedure: magnetic resonance imaging Procedure: positron emission tomography Procedure: quality-of-life assessment	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Masking:

Single

Primary Purpose:

Supportive Care

Official Title:

Complimentary Hyperbaric Oxygen for Brain Radionecrosis

Study Start Date :

Sep 1, 2003

Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Vasogenic edema volume by MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []
Lesion volume (contrast enhancement and necrotic core) by MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []
Neurologic status, including mental status, cranial nerves, motor function, sensory function, reflexes, coordination, and gait at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []
Health-related quality of life by Short Form-36 Health Survey and General Well-Being Schedule at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []
Revascularization by perfusion MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []
Survival every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []
Drop-out rate by steroid dosage at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []
Tumor progression by physical examination, positron emission tomography scans, and MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []
Brain radionecrosis progression by MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []
Adverse events (e.g., events related to barotrauma and oxygen or steroid toxicity) at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Definitive diagnosis of brain radionecrosis by MRI and positron emission tomography scan
Clinically symptomatic with signs of worsening neurologic deficits (e.g., focal deficits or intractable seizures)
Condition currently managed with increasing steroid dosage

PATIENT CHARACTERISTICS:

No severe pulmonary disease (i.e., untreated pneumothorax, emphysema, chronic obstructive pulmonary disease, or asthma)
No active congestive heart failure
LVEF ≥ 35%
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No psychological, familial, sociological, or geographical conditions that would preclude study compliance