Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis in Patients With Nasopharyngeal Carcinoma After Radiotherapy
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The change in LENT/SOMA scale scores at three months after treatment from base line.
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.
At three months after treatment
Yamei Tang, M.D.,PhD.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
China: Food and Drug Administration