Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis

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Brief Title

Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis

Official Title

Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis in Patients With Nasopharyngeal Carcinoma After Radiotherapy

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.

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

The change of the maximum area of the necrosis lesion on MRI three months after treatment

Secondary Outcome

 The change in LENT/SOMA scale scores at three months after treatment from base line

Condition

Nasopharyngeal Carcinoma

Intervention

Edaravone

Study Arms / Comparison Groups

 Edaravone group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

154

Start Date

March 2009

Completion Date

September 2012

Primary Completion Date

October 2011

Eligibility 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 /= 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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Yamei Tang, M.D.,PhD., ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT01865201

Organization ID

2009001

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Sponsor

Yamei Tang, M.D.,PhD., Principal Investigator, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Verification Date

December 2013