Ketogenic Diet for Patients With Recurrent Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability
研究概览
简要总结
To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma
详细描述
Increased glycolysis and reduced oxidative phosphorylation is a characteristic property of many tumors. A change of nutrition 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 therefore inhibit tumor growth. Standard treatment for glioblastoma includes resection, irradiation and temozolomide chemotherapy. If there is tumor recurrence, no standard therapy is established. Therapeutic options in this situation include resection, irradiation or another chemotherapy. However, some patients cannot be treated in this situation, because none of the available treatment options seems reasonable or applicable, for example if no additional chemotherapy can be started at the time of recurrence due to myelosuppression. The pilot study examines whether in this situation a ketogenic diet 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
- 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
- •age >= 18 years
- •histological diagnosis of glioblastoma or gliosarcoma
- •on MRI measurable tumor
- •interval of at least 6 months after primary resection
- •completed radiotherapy, interval of at least 3 months after completion of radiotherapy
- •relapse during or after temozolomide chemotherapy, other chemotherapy not possible, not reasonable or not wanted by the patient
- •Karnofsky-Index >= 60%, ECOG <= 2
- •life expectancy of at least 12 weeks
- •creatinine <= 1.5 mg/dl, urea <= 50 mg/dl
- •INR <= 1,5, GOT <= 7 x of normal value, GPT <= 7 x of normal value
排除标准
- •bowel obstruction or subileus
- •diabetes mellitus, HbA1c > 6,1 %
- •heart failure (NYHA > 2), myocardial infarction within the last 6 months, atrial fibrillation
- •acute infection
- •conditions that may strongly reduce compliance to the diet or increase risk of the diet
- •dementia or clinically relevant alterations of the mental state which interfere with the applicability of the diet
结局指标
主要结局
Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability
时间窗: until progression for up to 12 months
percentage of patients who discontinued diet due to intolerability
次要结局
- Progression-free-survival(until progression for up to 12 months)
- Overall Survival(death/last contact, an average of about 1 year)
- Frequency of Seizures(while on study treatment for up to 12 months)
- Ketosis(while on study treatment for up to 12 months)
- Quality of Life(while on study treatment for up to 12 months)
研究者
J. Rieger
Dr. Johannes Rieger
University Hospital Tuebingen