NCT01884987Unknown不适用
Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The necrotic volume showed on MRI
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: GM1 (Drug)
结局指标
主要结局
The necrotic volume showed on MRI
时间窗: 6-8 months
次要结局
- relief of the symptoms related to CRN(6-8 months)
研究者
研究点 (1)
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