Cerebral Radiation Necrosis, MRI, Nasopharyngeal Carcinoma, Radiotherapy
Conditions
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.
Interventions
DRUGGM1
This group will be treated with GM1 80mg daily for 14 days, and then followed with GM1 40mg daily for 46 days.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The necrotic volume showed on MRI | 6-8 months |
Secondary
| Measure | Time frame |
|---|---|
| relief of the symptoms related to CRN | 6-8 months |
Countries
China
Contacts
Primary ContactChaoSu Hu, MD, PhD
Backup ContactXiaoShen Wang, MD, PhD
Outcome results
None listed