Status:
UNKNOWN
Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain
Lead Sponsor:
Barrett Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Eligibility:
All Genders
Phase:
NA
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 ef...
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 bra...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00087815
Start Date
September 1 2003
End Date
June 1 2005
Last Update
December 18 2013
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0769