Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)

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Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04461938
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Goethe University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael W. Ronellenfitsch, Prof. Dr. Dr.
Principal Investigator Affiliation	Goethe University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Mixed

Arms & Interventions

Arms

Other: Fasting

All study participants follow the same dietary intervention; thus, no randomization will take place.

Interventions

Other: - Fasting

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Frankfurt, Hessen, Germany

Status

Address

Dr. Senckenberg Institute of Neurooncology, University Medicine Fankfurt, Goethe-University

Frankfurt, Hessen, 60590

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