Clinical trial NCT04461938: Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)
Official title: Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glioma, Mixed
Keywords: metabolism-nutritional intervention-ketogenic diet-fasting
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes in metabolism - induction of ketosis
timeFrame: 5 days
measure: General metabolic changes
timeFrame: 5 days
measure: Immunological changes
timeFrame: 5 days
measure: Alterations in electric brain activity
timeFrame: 5 days
Secondary outcomes:
measure: Intake of fluids and calories reported by dietary diary
timeFrame: 5 days
measure: Assessment to measure the tolerability of the diet by questionnaire
timeFrame: 5 days
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Dr. Senckenberg Institute of Neurooncology, University Medicine Fankfurt, Goethe-University
state: Hessen
Study officials:
affiliation: Goethe University
name: Michael W. Ronellenfitsch, Prof. Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.