DRKS00021734
Recruiting
Early Phase 1
Characterization of metabolic changes in the glioma tumor tissue induced by transient fasting: a pilot study
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main0 sites30 target enrollmentMay 12, 2020
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- C71
- Sponsor
- Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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) \<\= 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
- •uncontrolled thyroid function
- •pancreatic insufficiency
Outcomes
Primary Outcomes
Not specified
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