Feasibility of standard therapy with temozolomide and radiotherapy combined with ketogenic diet in patients with glioblastoma multiforme - Ketogenic therapy in patients with glioblastoma multiforme

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方