Nasopharyngeal Carcinoma Clinical Trial
Official title:
Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis in Patients With Nasopharyngeal Carcinoma After Radiotherapy
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.
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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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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