Status:
ACTIVE_NOT_RECRUITING
Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)
Lead Sponsor:
Goethe University
Conditions:
Glioma, Mixed
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04461938
Start Date
August 19 2020
End Date
June 30 2025
Last Update
October 17 2024
Active Locations (1)
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1
Dr. Senckenberg Institute of Neurooncology, University Medicine Fankfurt, Goethe-University
Frankfurt am Main, Hesse, Germany, 60590