Ketogenic Diet for Recurrent Glioblastoma

Study Overview
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Brief Summary
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To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma

Detailed Description
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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.

Official Title
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Ketogenic Diet for Patients With Recurrent Glioblastoma

Conditions
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Recurrent Glioblastoma

Intervention / Treatment
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* Dietary Supplement: TAVARLIN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ketogenic diet | Dietary Supplement: TAVARLIN<br>* ketogenic diet, dietary supplementary products provided by TAVARLIN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability | percentage of patients who discontinued diet due to intolerability | until progression for up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free-survival | measured by Macdonald-Criteria | until progression for up to 12 months | 
| Overall Survival | Participants were followed until reported death or last contact until 05/2011 | death/last contact, an average of about 1 year | 
| Frequency of Seizures |  | while on study treatment for up to 12 months | 
| Ketosis |  | while on study treatment for up to 12 months | 
| Quality of Life |  | while on study treatment for up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioblastoma, ketogenic diet