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Nutritional interventions such as ketogenic diet (KD) or fasting are currently under evaluation as anti-cancer treatment. In glioma patient cohorts, the feasibility and safety of fasting in addition to antitumor treatment has been shown. However, it is still unclear whether fasting exerts effects on the glioma tumor tissue at all, and whether fasting causes metabolic or immunological changes in the glioma microenvironment that could be exploited therapeutically. Therefore, the central contribution of this study is to characterize metabolic and immunological changes in the glioma tumor tissue induced by a fasting cycle of 72 hours prior to biopsy or resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting | Other | All study participants follow the same dietary intervention; thus, no randomization will take place. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting | Other | The study intervention consists of one fasting cycle of 72 hours prior to biopsy/resection. Depending on clinical condition, patients can be hospitalized during the course of the study (e.g. need for medical assistance due to immobilization). Patients in good clinical condition will be admitted on day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in metabolism - induction of ketosis | The presence of ketone bodies in patient blood will be assessed by capillary sampling from a finger or an ear lobe. The presence of ketone bodies in urine will be assessed by urine test strips. | 5 days |
| General metabolic changes | Main target parameters of MR spectroscopic imaging are detection of intracerebral ketone bodies (acetone, acetoacetate, beta-hydroxybutyrate), changes in lactate and adenosine triphosphate / adenosine diphosphate (ATP/ADP) concentrations and changes in intracellular pH (pHi) as determined from the chemical shift difference between inorganic phosphate (Pi) and phosphocreatine (PCr). Tumor tissue and healthy appearing normal white matter of the contralateral hemisphere will be examined. Tumor tissue will be analysed by metabolome and proteome analysis and RNA sequencing. Patient serum will be analysed by proteome analysis. | 5 days |
| Immunological changes | Flow cytometry including T- and B-lymphocytes natural killer (NK) cells in blood samples. Analysis of gut microbiome prior to and following fasting. | 5 days |
| Alterations in electric brain activity | Non-invasive electroencephalography (EEG) will be performed prior to and following fasting. It will be assessed with regard to chief frequencies and the presence of epilepsy-associated manifestations (e.g. epileptiform discharges, seizures). | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intake of fluids and calories reported by dietary diary | Patients will be asked keep a dietary diary for days 0 to 4 reporting on their intake of fluids and/or calories. | 5 days |
| Assessment to measure the tolerability of the diet by questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W. Ronellenfitsch, Prof. Dr. Dr. | Goethe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Senckenberg Institute of Neurooncology, University Medicine Fankfurt, Goethe-University | Frankfurt am Main | Hesse | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38722043 | Result | Alcicek S, Dive I, Thomas DC, Prinz V, Forster MT, Czabanka M, Weber KJ, Steinbach JP, Ronellenfitsch MW, Hattingen E, Pilatus U, Wenger KJ. 2D 1H sLASER Long-TE and 3D 31P Chemical Shift Imaging at 3 T for Monitoring Fasting-Induced Changes in Brain Tumor Tissue. J Magn Reson Imaging. 2025 Jan;61(1):426-438. doi: 10.1002/jmri.29422. Epub 2024 May 9. |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
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A short questionnaire of 8 aspects concerning the tolerability of the diet will be handed out. The patients will be asked to grade their consensus to each statement by 1 to 5 where "1" is defined as "not at all" and 5 as "very relevant" for daily life.
| 5 days |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |