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NCT Number: NCT04461938

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Glioma, Mixed Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fasting

Other

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 outcomes

  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.

    Patient serum will be analysed by proteome analysis.

  3. Immunological changes

    Time frame: 5 days

    Flow cytometry including T- and B-lymphocytes natural killer (NK) cells in blood samples.

    Analysis of gut microbiome prior to and following fasting.

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Acronym: ERGO3

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Jul 8, 2020
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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