Brain and Central Nervous System Tumors Clinical Trial
Official title:
Complimentary Hyperbaric Oxygen for Brain Radionecrosis
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 |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | June 2005 |
Est. primary completion date | |
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 |
Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Barrett Cancer Center | National Cancer Institute (NCI) |
United States,
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 |
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