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Treatment of Cerebral Radiation Necrosis (CRN) With Nerve Growth Factor (NGF)

Completed
Conditions
Cerebral Necrosis
Nashopharyngeal Cancer
Nerve Growth Factor
Interventions
Drug: NGF group
Registration Number
NCT02032147
Lead Sponsor
Fudan University
Brief Summary

Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF) to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective study to test the efficacy of NGF for CRN.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months.
Exclusion Criteria
  • CRN combined with local or regional relapse, or with distant metastasis.
  • CRN combined with other cerebrovascular disease.
  • CRN combined with the second primary malignancy.
  • CRN without neurologic symptoms or signs.
  • CRN combined with diabetes.
  • CRN patients that were supposed to live less than 6 months.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
NGF groupNGF groupThis group will be treated with NGF 18u daily for 60 days.
Primary Outcome Measures
NameTimeMethod
efficacy of using NGF for treating CRN6-8 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Shanghai Cancer Center, Fudan University

🇨🇳

Shanghai, Shanghai, China

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