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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04461938
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Ronellenfitsch, Goethe University

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.

Condition or disease Intervention/treatment Phase
Glioma, Mixed Other: Fasting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Fasting
All study participants follow the same dietary intervention; thus, no randomization will take place.
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.




Primary Outcome Measures :
  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 Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Michael W Ronellenfitsch, PD 0049696301 ext 87712 Michael.ronellenfitsch@kgu.de
Contact: Iris Divé, Dr 0049696301 ext 87712 Iris.dive@kgu.de

Locations
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Germany
Goethe University/Dr. Senckenbergischen Instituts für Neuroonkologie Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Michael W Ronellenfitsch, PD    0049696301 ext 87712    Michael.ronellenfitsch@kgu.de   
Contact: Iris Divé, Dr    0049696301 ext 87712    Iris.dive@kgu.de   
Sponsors and Collaborators
Goethe University
Investigators
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Principal Investigator: Michael W Ronellenfitsch, PD Goethe University
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Responsible Party: Michael Ronellenfitsch, Princial Investigator, Goethe University
ClinicalTrials.gov Identifier: NCT04461938    
Other Study ID Numbers: ERGO3
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Ronellenfitsch, Goethe University:
metabolism-nutritional intervention-ketogenic diet-fasting
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue