Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study
- Conditions
- RadiotherapyNasopharyngeal CarcinomaCerebral Radiation NecrosisMRI
- Interventions
- Registration Number
- NCT01884987
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description group one will receive non-GM1 conservative therapy GM1 Group one will receive conservative therapy such as hyperbaric therapy or corticosteroids therapy or "wait and see" policy
- Primary Outcome Measures
Name Time Method The necrotic volume showed on MRI 6-8 months
- Secondary Outcome Measures
Name Time Method relief of the symptoms related to CRN 6-8 months
Trial Locations
- Locations (1)
Shanghai Cancer Center, Fudan University
🇨🇳Shanghai, China