Ketogenic diet as adiuvant treatment in adults with glioblastoma multiforme
Completed
- Conditions
- Glioblastoma Multiforme, ketogenic diet, feasbility, safety, adults, brain cancer, ketosis
- Registration Number
- NL-OMON19917
- Lead Sponsor
- ErasmusMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
Inclusion criteria part A
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Neurological deficit in language or cognitive functions causing inability to fully understand the study protocol and requirements
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method umber 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 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 progression or death (whichever comes first).<br /><br>- Evaluation of neurological functioning will be evaluated by using the Vineland behavior scale (Appendix H) at baseline and at end of protocol treatment.<br /><br>- A questionnaire for the patients and caretakers on the manner of coping with the diet in daily practice will be filled out by the patient and by the partner/family member at baseline, after 8 weeks and at the end of protocol treatment.<br /><br>- Toxicity (i.e. adverse events CTCAE grade ¡Ý 2).