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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Complimentary Hyperbaric Oxygen for Brain Radionecrosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00087815
• Other study ID #: CDR0000510427
• Secondary ID: UCMC-02101007
• Status: Active, not recruiting
• Phase: N/A
• First received: July 14, 2004
• Last updated: December 17, 2013
• Start date: September 2003
• Est. completion date: June 2005

Study information

• Verified date: July 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Cognitive/Functional Effects
• Nervous System Neoplasms
• Radiation Injuries
• Radiation Toxicity

Intervention

Drug:
• dexamethasone

• hyperbaric oxygen

Procedure:
• cognitive assessment

• magnetic resonance imaging

• positron emission tomography

• quality-of-life assessment

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Barrett Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Survival every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Primary	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
Primary	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
Primary	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
Primary	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