C71
Conditions
Interventions
Group 1: fasting cycle of 72 hours prior to biopsy or resection.
Sponsors
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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) 100000/µl, leukocytes > 3000/µl
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactMichael Ronellenfitsch
Universitätsklinikum Frankfurt Dr. Senckenbergischen Instituts für Neuroonkologie
Outcome results
None listed