Recurrent Glioblastoma
Conditions
Keywords
glioblastoma, ketogenic diet
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.
Interventions
DIETARY_SUPPLEMENTTAVARLIN
ketogenic diet, dietary supplementary products provided by TAVARLIN
Sponsors
Evomed MedizinService GmbH
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability | until progression for up to 12 months | percentage of patients who discontinued diet due to intolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free-survival | until progression for up to 12 months | measured by Macdonald-Criteria |
| Overall Survival | death/last contact, an average of about 1 year | Participants were followed until reported death or last contact until 05/2011 |
| 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 | — |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketogenic Diet ketogenic diet | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Ketogenic Diet |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment Germany | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability
percentage of patients who discontinued diet due to intolerability
Time frame: until progression for up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketogenic Diet | Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability | 15 percent of participants |
Secondary
Frequency of Seizures
Time frame: while on study treatment for up to 12 months
Secondary
Ketosis
Time frame: while on study treatment for up to 12 months
Secondary
Overall Survival
Participants were followed until reported death or last contact until 05/2011
Time frame: death/last contact, an average of about 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketogenic Diet | Overall Survival | 32 weeks |
Secondary
Progression-free-survival
measured by Macdonald-Criteria
Time frame: until progression for up to 12 months
Population: for the analyis of PFS and OS, 3 patients who discontinued the diet in the absence of progression were excluded
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketogenic Diet | Progression-free-survival | 5 weeks |
Secondary
Quality of Life
Time frame: while on study treatment for up to 12 months