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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioma, Mixed

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fasting

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

Group Type OTHER

Fasting

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No