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JOURNAL ONKOLOGIE – STUDIE
ERGO3

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

Rekrutierend

NCT-Nummer:
NCT04461938

Studienbeginn:
August 2020

Letztes Update:
09.02.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Glioma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Goethe University

Collaborator:
-

Studienleiter

Michael W Ronellenfitsch, PD
Principal Investigator
Goethe University

Kontakt

Michael W Ronellenfitsch, PD
Kontakt:
Phone: 0049696301
Phone (ext.): 87712
E-Mail: Michael.ronellenfitsch@kgu.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Goethe University/Dr. Senckenbergischen Instituts für Neuroonkologie
60590 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Michael W Ronellenfitsch, PD
Phone: 0049696301
Phone (ext.): 87712
E-Mail: Michael.ronellenfitsch@kgu.de

Iris Divé, Dr
Phone: 0049696301
Phone (ext.): 87712
E-Mail: Iris.dive@kgu.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Changes in metabolism - induction of ketosis (Time Frame - 5 days):
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.

2. General metabolic changes (Time Frame - 5 days):
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.

3. Immunological changes (Time Frame - 5 days):
Flow cytometry including T- and B-lymphocytes natural killer (NK) cells in blood samples.

4. alterations in electric brain activity (Time Frame - 5 days):
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).

Secondary outcome:

1. Intake of fluids and calories reported by dietary diary (Time Frame - 5 days):
Patients will be asked keep a dietary diary for days 0 to 4 reporting on their intake of fluids and/or calories.

2. Assessment to measure the tolerability of the diet by questionnaire (Time Frame - 5 days):
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.

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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