Clinical trial · Interventional
Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)
NCT04461938CI-TRIAL-00081708ERGO3active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma, Mixed | Mixed Glioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fasting | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Fasting
- description
- All study participants follow the same dietary intervention; thus, no randomization will take place.
- interventionNames
- Other: Fasting
Primary outcomes (4)
- measure
- Changes in metabolism - induction of ketosis
- timeFrame
- 5 days
- description
- 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.
- measure
- General metabolic changes
- timeFrame
- 5 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * suspicion of glioma World Health Organization (WHO) grade II, III or IV as assessed by cerebral imaging (MRI) * MRI-suspected relapse of previously diagnosed glioma * interdisciplinary recommendation for resection or biopsy * karnofsky performance status \>= 60, Eastern Cooperative Oncology Group Performance Status (ECOG) \<= 2 * creatinine \<= 2,0 mg/dl, urea \<= 100 mg/dl * alanine aminotransferase (ALAT), alanine aminotransferase aspartate transaminase (ASAT) \<= 7x upper normal limit * international normalized ratio (INR) ≤ 1,5, thrombocytes \> 100000/µl, leukocytes \> 3000/µl Exclusion Criteria: * bowel obstruction, subileus * insulin-dependent diabetes * dexamethasone \>4mg/day * decompensated heart failure (NYHA \> 2) * myocardial infarction within the last 6 months, symptomatic atrial fibrillation * severe acute infection or clinically relevant immunosuppression (HIV infection, granulocytopenia \<1000/ µl, lymphocytopenia \<500/ µl * malnutrition, cachexia (BMI \<18) * other medical conditions that might increase the risk of the dietary intervention * pregnancy * uncontrolled thyroid function * pancreatic insufficiency * dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study * major contraindications to MRI scanning (e.g. presence of implanted MRI-incompatible cardiac devices)
References
Publications (1)
- RESULTAlcicek 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. PMID 38722043