Feasibility of standard therapy with temozolomide and radiotherapy combined with ketogenic diet in patients with glioblastoma multiforme
- Conditions
- Glioblastoma Multiforme10029211
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Feasibility of KD during standard treatment with RT and CT defined as<br /><br>successfully following the KD for 14 weeks after start of protocol treatment.<br /><br>So a patient is considered a failure for the primary endpoint if the KD is<br /><br>followed for less than 14 weeks from start of protocol treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Number of days on KD after start protocol treatment<br /><br>- Compliance to the KD reflected in adequate and stable ketosis (3-4 mmol/l).<br /><br>- Number of withdrawals or not reaching ketosis <3 mmol/L during the first 10<br /><br>days of the KD<br /><br>- Overall survival (OS) defined as time from diagnosis till date of death<br /><br>- Progression free survival (PFS) defined as time from diagnosis till tumor<br /><br>progression or death (whichever comes first).<br /><br>- Evaluation of neurological functioning will be evaluated by using the<br /><br>Vineland behavior scale (Appendix X) at baseline, after 8 weeks and at end of<br /><br>protocol treatment.<br /><br>- Toxicity (i.e. adverse events CTCAE grade * 2).</p><br>