Glioblastoma Multiforme
Conditions
Interventions
Addition of KD to standard treatment.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part A: - 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
Exclusion criteria
Exclusion criteria: - 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of KD during standard treatment with RT and CT defined as successfully following the KD for 14 weeks after start of protocol treatment. So a patient is considered a failure for the primary endpoint if the KD is followed for less than 14 weeks from start of protocol treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of days on KD after start protocol treatment - Compliance to the KD reflected in adequate and stable ketosis (3-4 mmol/l). - Number of withdrawals or not reaching ketosis | — |
Countries
Netherlands
Outcome results
None listed