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

NCT ID: NCT00087815

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2005-06-30

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.

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.

Conditions

Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Radiation Toxicity

Keywords

cognitive/functional effects; radiation toxicity; adult brain tumor; childhood brain tumor

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Interventions

dexamethasone

Intervention Type: DRUG

hyperbaric oxygen

Intervention Type: DRUG

cognitive assessment

Intervention Type: PROCEDURE

magnetic resonance imaging

Intervention Type: PROCEDURE

positron emission tomography

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior or concurrent bleomycin
• No concurrent doxorubicin hydrochloride
• No concurrent disulfiram

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barrett Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Laurie Gesell, MD

Role: PRINCIPAL_INVESTIGATOR

Barrett Cancer Center

Locations

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

UCMC-02101007

Identifier Type: -

Identifier Source: secondary_id

CDR0000510427

Identifier Type: -

Identifier Source: org_study_id