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Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis

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ClinicalTrials.gov Identifier: NCT01865201
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary:
It is hypothesized that excessive generation of free radicals involves in the pathogenesis of radiation-induced brain necrosis. This study therefore evaluated the effect of free radical scavenger, edaravone, on radiation-induced temporal lobe necrosis (TLN) in patients with nasopharyngeal carcinoma (NPC) after radiotherapy.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Brain Necrosis Drug: Edaravone Other: Common fundamental management Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis in Patients With Nasopharyngeal Carcinoma After Radiotherapy
Study Start Date : March 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Edaravone

Arm Intervention/treatment
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.
Drug: Edaravone
Be used at a dose of 30mg, intravenously, twice per day, for 14 days.
Other Name: 3-Methyl-1-phenyl-2-pyrazolin-5-one

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.
Other: 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 Names:
  • Methlprednisolone
  • Mannitol




Primary Outcome Measures :
  1. The change of the maximum area of the necrosis lesion on MRI three months after treatment [ Time Frame: At three months after treatment ]
    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.


Secondary Outcome Measures :
  1. The change in LENT/SOMA scale scores at three months after treatment from base line [ Time Frame: Three months after treatment ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865201


Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Yamei Tang, M.D.,PhD. Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yamei Tang, Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01865201     History of Changes
Other Study ID Numbers: 2009001
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Keywords provided by Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
Radiotherapy
Radiation-induced brain necrosis
Edaravone
Effectiveness
Safety
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Necrosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Pathologic Processes
Prednisolone
Methylprednisolone
Edaravone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents