Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3) (ERGO3)
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|ClinicalTrials.gov Identifier: NCT04461938|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioma, Mixed||Other: Fasting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
All study participants follow the same dietary intervention; thus, no randomization will take place.
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.
- 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.
- 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.
- Immunological changes [ Time Frame: 5 days ]Flow cytometry including T- and B-lymphocytes natural killer (NK) cells in blood samples.
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461938
|Contact: Michael W Ronellenfitsch, PD||0049696301 ext 87712||Michael.firstname.lastname@example.org|
|Contact: Iris Divé, Dr||0049696301 ext 87712||Iris.email@example.com|
|Goethe University/Dr. Senckenbergischen Instituts für Neuroonkologie||Recruiting|
|Frankfurt, Hessen, Germany, 60590|
|Contact: Michael W Ronellenfitsch, PD 0049696301 ext 87712 Michael.firstname.lastname@example.org|
|Contact: Iris Divé, Dr 0049696301 ext 87712 Iris.email@example.com|
|Principal Investigator:||Michael W Ronellenfitsch, PD||Goethe University|