Ketogenic Diet for Patients With Recurrent Glioblastoma
18 Years
N/A
Both
Recurrent Glioblastoma
Trial Information
Ketogenic Diet for Patients With Recurrent Glioblastoma
Increased glycolysis and reduced oxidative phosphorylation is a characteristic property of
many tumors. A change of nutrition by limiting carbohydrates and increasing the proportion
of fatty acids and proteins can lead to ketogenic metabolism and might limit energy
production in tumor cells and therefore inhibit tumor growth. Standard treatment for
glioblastoma includes resection, irradiation and temozolomide chemotherapy. If there is
tumor recurrence, no standard therapy is established. Therapeutic options in this situation
include resection, irradiation or another chemotherapy. However, some patients cannot be
treated in this situation, because none of the available treatment options seems reasonable
or applicable, for example if no additional chemotherapy can be started at the time of
recurrence due to myelosuppression. The pilot study examines whether in this situation a
ketogenic diet can be applied to the patients and may inhibit tumor growth and influence the
quality of life of the patients.
Inclusion Criteria:
- age >= 18 years
- histological diagnosis of glioblastoma or gliosarcoma
- on MRI measurable tumor
- interval of at least 6 months after primary resection
- completed radiotherapy, interval of at least 3 months after completion of
radiotherapy
- relapse during or after temozolomide chemotherapy, other chemotherapy not possible,
not reasonable or not wanted by the patient
- Karnofsky-Index >= 60%, ECOG <= 2
- life expectancy of at least 12 weeks
- creatinine <= 1.5 mg/dl, urea <= 50 mg/dl
- INR <= 1,5, GOT <= 7 x of normal value, GPT <= 7 x of normal value
Exclusion Criteria:
- bowel obstruction or subileus
- diabetes mellitus, HbA1c > 6,1 %
- heart failure (NYHA > 2), myocardial infarction within the last 6 months, atrial
fibrillation
- acute infection
- conditions that may strongly reduce compliance to the diet or increase risk of the
diet
- dementia or clinically relevant alterations of the mental state which interfere with
the applicability of the diet
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
applicability as measured by discontinuation of study treatment due to intolerability and percentage of patients in which ketosis is detectable
Outcome Time Frame:
until progression for up to 12 months
Safety Issue:
Yes
Principal Investigator
Johannes Rieger, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Senckenberg Institute of Neurooncology, University of Frankfurt
Authority:
Germany: Ethics Commission
Study ID:
ERGO
NCT ID:
NCT00575146
Start Date:
December 2007
Completion Date:
February 2010
Related Keywords:
- Recurrent Glioblastoma
- glioblastoma
- ketogenic diet
- Glioblastoma
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