- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01865201
Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis
Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis in Patients With Nasopharyngeal Carcinoma After Radiotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Radiation-induced temporal lobe necrosis (TLN) is the most serious sequelae of radiotherapy and impairs the patients' quality of life profoundly. Steroid is one of the conventional treatment methods for TLN. However, its response rate was still not so satisfactory (about 30%-35%).The mechanism of TLN is under exploring and not completely understood. It has been proposed recently that chronic oxidative stress and inflammation involve in the pathogenesis of radiation-induced late normal tissue injury.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
①Patients must have received radiation therapy for histologically confirmed nasopharyngeal carcinoma.
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:
①Tumor recurrence or metastases.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Be used at a dose of 30mg, intravenously, twice per day, for 14 days.
Other Names:
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Experimental: 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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of the maximum area of the necrosis lesion on MRI three months after treatment
Time Frame: At three months after treatment
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The radiographic response was assessed by difference between MRI pretreatment and post-treatment, which included T1-weighted gadolinium contrast-enhanced and T2-weighted image.
The maximum area measurement of the radiation necrosis lesions were recorded (the product of the longest trans diameter and its longest perpendicular).
And the change of the maximum area of the necrosis lesion on MRI three months after treatment was used as the secondary end point.
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At three months after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in LENT/SOMA scale scores at three months after treatment from base line
Time Frame: Three months after treatment
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Clinical symptoms and signs were evaluated by Late Effects of Normal Tissues -Subjective, Objective, Management, Analytic (LENT/SOMA) scale(16) before drug administration and three months after treatment.
Subjective domain contains five items: headache, somnolence, intellectual deficit, functional competence, and memory.
Objective domain contains four items: neurologic deficit, cognitive functions, mood & personality changes, and seizures.
And Analytic domain includes neuropsychologic and radiologic assessments.
Each domain scores from 0 to 4. The summary of each domain represents the final score of LENT/SOMA scale.
The primary end point was the change in LENT/SOMA scale scores at three months after treatment from base line.
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Three months after treatment
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Collaborators and Investigators
Investigators
- Principal Investigator: Yamei Tang, M.D.,PhD., Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Necrosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Neuroprotective Agents
- Protective Agents
- Natriuretic Agents
- Diuretics, Osmotic
- Diuretics
- Antioxidants
- Free Radical Scavengers
- Mannitol
- Edaravone
Other Study ID Numbers
- 2009001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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