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

NCT00087815 | Unknown

• 2 other identifiers: CDR0000510427UCMC-02101007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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

Interventions

dexamethasone DRUG

hyperbaric oxygen DRUG

cognitive assessment PROCEDURE

magnetic resonance imaging PROCEDURE

positron emission tomography PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barrett Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0769, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Radiation Injuries; Brain Neoplasms

Interventions

Dexamethasone; Hyperbaric Oxygenation; Mental Status and Dementia Tests; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Laurie Gesell, MD

  Barrett Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2004
• First Posted: July 16, 2004
• Study Start: September 1, 2003
• Study Completion: June 1, 2005
• Last Updated: December 18, 2013

Record last verified: 2007-07

Locations

US (1)