Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis
NCT ID: NCT01865201
Last Updated: 2013-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2009-03-31
2012-09-30
Brief Summary
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Detailed Description
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Edaravone(3-methyl-1-phenyl-2-pyrazolin-5-one), which is proved to be an excellent free radical scavenger, has been applied to a wide range of oxidative stress-related diseases.Thus, it may exert a therapeutic effect on radiation-induced temporal lobe necrosis. To support this hypothesis, the investigators carried out a randomized study of combining edaravone with common fundamental management versus common fundamental therapy in patients with TLN, and analyzed the Late Effects of Normal Tissues -Subjective, Objective, Management, Analytic (LENT/SOMA) scale before and after treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Edaravone group
Edaravone was used at a dose of 30mg,intravenously, twice per day, for 14 days. All patients also received common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.
Edaravone
Be used at a dose of 30mg, intravenously, twice per day, for 14 days.
Control group
All patients in this group received common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.
Common fundamental management
common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.
Interventions
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Edaravone
Be used at a dose of 30mg, intravenously, twice per day, for 14 days.
Common fundamental management
common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior irradiation \>/= 6 months prior to study entry.
* Radiographic evidence to support the diagnosis of radiation-induced temporal lobe necrosis without tumor recurrence(15).
* Age\>/= 18 years.
* No evidence of very high intracranial pressure that suggests brain hernia and need surgery.
* Fertile women who are willing to take contraception during the trial.
* Routine laboratory studies with bilirubin \</=2 \* upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) \< 2 \* ULN, creatinine \<1.5 \* ULN, red-cell count \>/= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; Hb \>/=9.0. prothrombin time(PT), activated partial thromboplastin time(APTT),international normalized ratio(INR) in a normal range.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria
* Diseases of central nervous system, such as cerebral vascular events, inflammatory, degenerative disease, and significant cardiovascular diseases.
* Severe systemic diseases.
* History of anaphylactic response to edaravone.
18 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Yamei Tang
Professor
Principal Investigators
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Yamei Tang, M.D.,PhD.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
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References
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Tang Y, Rong X, Hu W, Li G, Yang X, Yang J, Xu P, Luo J. Effect of edaravone on radiation-induced brain necrosis in patients with nasopharyngeal carcinoma after radiotherapy: a randomized controlled trial. J Neurooncol. 2014 Nov;120(2):441-7. doi: 10.1007/s11060-014-1573-4. Epub 2014 Aug 21.
Related Links
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The homepage of Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Other Identifiers
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2009001
Identifier Type: -
Identifier Source: org_study_id