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Clinical Trials/DRKS00021734
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.

Registry
who.int
Start Date
May 12, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

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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