NCT01884987

Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Radiotherapy
• Nasopharyngeal Carcinoma
• Cerebral Radiation Necrosis
• MRI

Interventions

Type	Name	Description
DRUG	GM1	This group will be treated with GM1 80mg daily for 14 days, and then followed with GM1 40mg daily for 46 days.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-06-24
• Last updated: 2014-01-07

Locations

1 site across 1 country: China