DRKS00021734招募中早期 1 期
Characterization of metabolic changes in the glioma tumor tissue induced by transient fasting: a pilot study
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main0 个研究点目标入组 30 人开始时间: 2020年5月12日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •age >= 18 years
- •suspicion of glioma World Health Organization (WHO) grade II, III or IV as assessed by cerebral imaging (MRI)
- •MRI-suspected relapse of previously diagnosed glioma
- •interdisciplinary recommendation for resection or biopsy
- •karnofsky performance status >= 60, Eastern Cooperative Oncology Group Performance Status (ECOG) <= 2
- •creatinine <= 2,0 mg/dl, urea <= 100 mg/dl
- •ALAT, ASAT <= 7x upper normal limit
- •INR = 1,5, thrombocytes > 100000/µl, leukocytes > 3000/µl
排除标准
- •bowel obstruction, subileus
- •insulin-dependent diabetes
- •dexamethasone >4mg/day
- •decompensated heart failure (NYHA > 2)
- •myocardial infarction within the last 6 months, symptomatic atrial fibrillation
- •severe acute infection or clinically relevant immunosuppression (HIV infection, granulocytopenia <1000/ µl, lymphocytopenia <500/ µl
- •malnutrition, cachexia (BMI <18)
- •other medical conditions that might increase the risk of the dietary intervention
- •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
- •major contraindications to MRI scanning (e.g. presence of implanted MRI-incompatible cardiac devices)
研究者
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