Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Evomed MedizinService GmbH | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine whether a mild ketogenic diet can influences quality of life and survival of 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ketogenic diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVARLIN | Dietary Supplement | ketogenic diet, dietary supplementary products provided by TAVARLIN |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johannes Rieger, MD | Senckenberg Institute of Neurooncology, University of Frankfurt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Senckenberg Institute of Neurooncology | Frankfurt | 60528 | Germany | |||
| Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24728273 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ketogenic Diet | unrestricted ketogenic diet (< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ketogenic Diet | ketogenic diet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability | percentage of patients who discontinued diet due to intolerability | Posted | Number | percent of participants | until progression for up to 12 months |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketogenic Diet | ketogenic diet |
Not provided
Not provided
Because of the small number of patients efficacy cannot be concluded by the results of the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Johannes Rieger | Dr. Senckenberg Institute of Neurooncology | +49 69 6301 | 87711 | johannes.rieger@med.uni-frankfurt.de |
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Tübingen |
| 72076 |
| Germany |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Progression-free-survival | measured by Macdonald-Criteria | for the analyis of PFS and OS, 3 patients who discontinued the diet in the absence of progression were excluded | Posted | Median | Full Range | weeks | until progression for up to 12 months |
|
|
|
| Secondary | Overall Survival | Participants were followed until reported death or last contact until 05/2011 | Posted | Median | Full Range | weeks | death/last contact, an average of about 1 year |
|
|
|
| Secondary | Frequency of Seizures | Not Posted | while on study treatment for up to 12 months |
| Secondary | Ketosis | Not Posted | while on study treatment for up to 12 months |
| Secondary | Quality of Life | Not Posted | while on study treatment for up to 12 months |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |