Clinical trial · Interventional
Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain
Complimentary Hyperbaric Oxygen for Brain Radionecrosis
NCT00087815CI-TRIAL-00013016unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive assessment | Procedure | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| hyperbaric oxygen | Drug | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (10)
- measure
- 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
- measure
- 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
- measure
- 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
- measure
- 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
- measure
- 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
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.