NL-OMON40862已完成不适用
Feasibility of standard therapy with temozolomide and radiotherapy combined with ketogenic diet in patients with glioblastoma multiforme - Ketogenic therapy in patients with glioblastoma multiforme
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histologically proven GBM (Astrocytoma WHO grade 4) after surgical resection
- •- Age * 18 years.
- •- Not dexamethasone dependent after surgery
- •- Amenable and planned for standard RT and CT and starting within 6 weeks after enrolment.
- •- Supportive partner or family member who can and is willing to help calculating, preparing and providing the meals.
- •- KPS *70.
- •- Written informed consent
- •- Able and willing to complete study specific diaries and questionnaires.
- •- Able to understand the procedures and instructions and able to give informed consent;Part B:
- •- Able to reach 3+ mmol/L ketosis within one week on the KD
- •- Abe to follow the KD during ketosis, for at least 3 days
排除标准
- •- Neurological deficit in language or cognitive functions causing inability to fully understand the study protocol and requirements
- •- Dementia or amnesia
- •- History of psychiatric disorder that would prohibit the understanding and giving of informed consent.
- •- The use of dexamethasone at time of registration
- •- Fatty acid disorders (like Medium Chain triglycerides disorders)
- •- Hypertriglyceridemia (> 10 mmol/L) despite treatment
- •- Hypercholesterolemia (> 7.5 mmol/L) despite treatment
- •- Alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) >2.5x ULN
- •- (History of) Kidney stones
- •- Diabetes mellitus
- •- (History of) Pancreatitis
- •- Acute/chronic gastro-intestinal disease(s) such as persistent diarrhea, colitis ulcerosa and M. Crohn
- •- Underweight (BMI < 16)
- •- Overweight (BMI >30)
- •- Untreated or uncontrolled hypertension
- •- Any other chronic or systemic disease or serious medical condition (other than related to GBM), that may influence protocol compliance or outcomes of the study significantly
研究者
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