Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-emergent Adverse Effects
研究概览
简要总结
Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro.
Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma.
详细描述
Diet change by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and inhibit tumor growth.
In a pilot of recurrent glioblastoma, ketogenic diet adjuvant salvage chemotherapy was given as interventional group and standard diet adjuvant salvage chemotherapy was given as control group.
The study examines whether a ketogenic diet adjunctive to salvage chemotherapy can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Karnovsky Performance Score of 60 or more.
- •histologically confirmed glioblastoma multiforme, grade 4
- •Ability and willingness to signed informed consent form.
- •Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy.
- •normal function of liver and kidney
排除标准
- •Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
- •History of uncontrolled hyperlipidemia or hyperglycemia.
- •History of human immunodeficiency virus, or hepatitis C
- •Pregnancy or breastfeeding
- •Inability or unwillingness of subject to give written informed consent
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Effects
时间窗: one year
Number of participants with treatment-emergent adverse effects while on ketogenic diet.
次要结局
- The Chemosensitivity of Tumor(one year)
- Overall Survival(one year)
- Ketosis(one year)
- Quality of Life(one year)
研究者
Song Lin
Proffessor
Beijing Tiantan Hospital