Characterization of metabolic changes in the glioma tumor tissue induced by transient fasting: a pilot study

Early Phase 1

Recruiting

Conditions: C71
Malignant neoplasm of brain

Registration Number: DRKS00021734

Lead Sponsor: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

age >= 18 years
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
ALAT, ASAT <= 7x upper normal limit
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 & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study is set up as a prospective pilot study and does not aim for therapeutic efficacy. Thus, clinical outcome measures do not apply. Outcome will be evaluated by changes in metabolism and immune profile. The central aim of this study is to assess these fasting-induced changes.

Secondary Outcome Measures