Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Progression-free-survival
研究概览
简要总结
Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.
Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18 years
- •recurrence of a histologically confirmed glioblastoma or gliosarcoma
- •at least 6 months after first surgery
- •at least 6 months after first radiotherapy
- •interdisciplinary recommendation for reirradiation
- •karnofsky performance status >= 60, ECOG <= 2
- •creatinine <= 2,0 mg/dl, urea <= 100 mg/dl
- •ALAT, ASAT <= 7x upper normal limit
排除标准
- •bowel obstruction, subileus
- •insulin-dependent diabetes
- •decompensated heart failure (NYHA > 2)
- •myocardial infarction within the last 6 months, symptomatic atrial fibrillation
- •severe acute infection
- •malnutrition, cachexia
- •other medical conditions that might increase the risk of the dietary intervention
- •pregnancy
- •uncontrolled thyroid function
- •pancreatic insufficiency
- •dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study
结局指标
主要结局
Progression-free-survival
时间窗: 6 months
Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)
次要结局
- Frequency of Seizures(day 1-12)
- Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9(day 1-12)
- Attention(day 1-12)
- Depression(day 1-12)
- Progression-free-survival(1 month, 3 months)
- Overall Survival(12 months)
- Quality of Life as Measured by the EORTC Quality of Life Questionnaire(day 1-12)
- Response(1 month)
- Safety and Tolerability as Defined as Number of Patients With Adverse Events(day 1-12)
- Ketosis(day 1-12)
研究者
Johannes Rieger
PD Dr. med.
Johann Wolfgang Goethe University Hospital