Clinical trial NCT00575146: Ketogenic Diet for Recurrent Glioblastoma
Official title: Ketogenic Diet for Patients With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Glioblastoma
Keywords: glioblastoma
ketogenic diet
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Evomed MedizinService GmbH
First posted: 2007-12-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability
timeFrame: until progression for up to 12 months
Secondary outcomes:
measure: Progression-free-survival
timeFrame: until progression for up to 12 months
measure: Overall Survival
timeFrame: death/last contact, an average of about 1 year
measure: Frequency of Seizures
timeFrame: while on study treatment for up to 12 months
measure: Ketosis
timeFrame: while on study treatment for up to 12 months
measure: Quality of Life
timeFrame: while on study treatment for up to 12 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Senckenberg Institute of Neurooncology
city: Tuebingen
country: Germany
facility: Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen
Study officials:
affiliation: Senckenberg Institute of Neurooncology, University of Frankfurt
name: Johannes Rieger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rieger J, Bahr O, Maurer GD, Hattingen E, Franz K, Brucker D, Walenta S, Kammerer U, Coy JF, Weller M, Steinbach JP. ERGO: a pilot study of ketogenic diet in recurrent glioblastoma. Int J Oncol. 2014 Jun;44(6):1843-52. doi: 10.3892/ijo.2014.2382. Epub 2014 Apr 11.