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

Goethe University

Status: Active, not recruiting

Conditions: Glioma, Mixed

Treatments: Other: Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT04461938

ERGO3

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Fasting

Other group

Description:

All study participants follow the same dietary intervention; thus, no randomization will take place.

Treatment:

Other: Fasting