Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

Fudan University30 enrolled

Overview

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 monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Radiotherapy Nasopharyngeal Carcinoma Cerebral Radiation Necrosis MRI

Interventions

GM1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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. ② CRN combined with other cerebrovascular disease. ③CRN combined with the second primary malignancy. ④ CRN without neurologic symptoms or signs. ⑤ CRN combined with diabetes. ⑥CRN patients that were supposed to live less than 6 months.

Outcomes

Primary Outcomes

The necrotic volume showed on MRI

Time frame: 6-8 months

Secondary Outcomes

relief of the symptoms related to CRN

Time frame: 6-8 months

Central Contacts

ChaoSu Hu, MD, PhD

CONTACT

86-21-64175590 hucsu62@126.com

XiaoShen Wang, MD, PhD