Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
试验速览
- 阶段
- 不适用
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Number of Participants With Ketosis
研究概览
简要总结
The purpose of this research study is to see if people can produce ketones in their blood with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your blood by restricting carbohydrates to <20 grams per day. Ketones are substances that are produced in the blood when fat is being broken down. Ketones may help radiation work better and may starve your tumor because it is thought that some brain tumors can not use ketones to grow and can only use sugar or glucose to grow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary malignant glioma, Grade III or IV
- •No uncontrolled infection or other active malignancy or chronic systemic immune therapy.
- •ECOG performance status <
- •Life expectancy > three months.
- •Adequate labs
排除标准
- •Diagnosis of genetic disorder of fat metabolism.
- •Type 2 diabetes diagnosed with a hemoglobin A1C > 6.4
- •Allergic to dairy or lactose intolerance
结局指标
主要结局
Number of Participants With Ketosis
时间窗: 6 weeks
Ketosis measured by serum beta-hydroxybuterate. Ketosis is defined as having serum beta-hydroxybuterate (BHB) at \> 0.05 mM. Participants' BHB levels were assessed at 6 weeks after starting the study. The number of participants who had BHB at \> 0.05 mM were considered to have entered into ketosis. 9 of 9 participants met this criteria.
次要结局
- Number of Participants With Progression Free Survival(6 months)
- Assessment of Survival(2 years)
研究者
Rekha Chaudhary
Associate Professor of Medicine
University of Cincinnati