- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461938
Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3) (ERGO3)
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael W Ronellenfitsch, PD
- Phone Number: 87712 0049696301
- Email: Michael.ronellenfitsch@kgu.de
Study Contact Backup
- Name: Iris Divé, Dr
- Phone Number: 87712 0049696301
- Email: Iris.dive@kgu.de
Study Locations
-
-
Hessen
-
Frankfurt, Hessen, Germany, 60590
- Recruiting
- Goethe University/Dr. Senckenbergischen Instituts für Neuroonkologie
-
Contact:
- Michael W Ronellenfitsch, PD
- Phone Number: 87712 0049696301
- Email: Michael.ronellenfitsch@kgu.de
-
Contact:
- Iris Divé, Dr
- Phone Number: 87712 0049696301
- Email: Iris.dive@kgu.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Fasting
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 days
|
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. |
5 days
|
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. |
5 days
|
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).
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 days
|
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.
|
5 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael W Ronellenfitsch, PD, Goethe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERGO3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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