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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group one will receive non-GM1 conservative therapy | Group one will receive conservative therapy such as hyperbaric therapy or corticosteroids therapy or "wait and see" policy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GM1 | Drug | This group will be treated with GM1 80mg daily for 14 days, and then followed with GM1 40mg daily for 46 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The necrotic volume showed on MRI | 6-8 months |
| Measure | Description | Time Frame |
|---|---|---|
| relief of the symptoms related to CRN | 6-8 months |
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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:
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Patients must have undergone definitive RT for histologically confirmed NPC years before. They were required to have at least two consecutive magnetic resonance imaging (MRI) study supporting the diagnosis of CRN with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI. The necrotic mass shown on MRI must be measured in two dimensions in order to define the response to treatment. Other radiologic studies were also required to support the non-existence of local or regional recurrence, distant metastasis. Patients must have undergone mental status examinations and had progressive neurologic symptoms or signs. In addition, they were required to have a Karnofsky performance status of at least 70 and were supposed to live more than 6 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ChaoSu Hu, MD, PhD | Contact | 86-21-64175590 | 1408 | hucsu62@126.com |
| XiaoShen Wang, MD, PhD | Contact | 86-21-64175590 | 6702 | ruijin702@163.com |
| Name | Affiliation | Role |
|---|---|---|
| ChaoSu Hu, MD, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Cancer Center, Fudan University | Recruiting | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005677 | G(M1) Ganglioside |
| ID | Term |
|---|---|
| D005732 | Gangliosides |
| D020384 | Acidic Glycosphingolipids |
| D006028 | Glycosphingolipids |
| D006017 | Glycolipids |
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|
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006001 |
| Glycoconjugates |
| D002241 | Carbohydrates |
| D008055 | Lipids |
| D013107 | Sphingolipids |
| D008563 | Membrane Lipids |