Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma
- Conditions
- Recurrent Glioblastoma
- Registration Number
- NCT01754350
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- Brief Summary
Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.
Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- age >= 18 years
- recurrence of a histologically confirmed glioblastoma or gliosarcoma
- at least 6 months after first surgery
- at least 6 months after first radiotherapy
- interdisciplinary recommendation for reirradiation
- karnofsky performance status >= 60, ECOG <= 2
- creatinine <= 2,0 mg/dl, urea <= 100 mg/dl
- ALAT, ASAT <= 7x upper normal limit
- bowel obstruction, subileus
- insulin-dependent diabetes
- decompensated heart failure (NYHA > 2)
- myocardial infarction within the last 6 months, symptomatic atrial fibrillation
- severe acute infection
- malnutrition, cachexia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Progression-free-survival 6 months Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)
- Secondary Outcome Measures
Name Time Method Frequency of Seizures day 1-12 frequency of seizures at day 1-12
Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9 day 1-12 Feasibility of the calorie-restricted, ketogenic diet and the transient fasting measured as median number of days on diet per patient and average calorie and carbohydrate intake per day during day 1-9
Attention day 1-12 attention as measured by d2-testing at day 1-12
Depression day 1-12 depression as measured by SCL-90 at day 1-12
Progression-free-survival 1 month, 3 months progression-free-survival rates 1 month and 3 month after reirradiation
Overall Survival 12 months overall survival after the reirradiation
Quality of Life as Measured by the EORTC Quality of Life Questionnaire day 1-12 Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire
Response 1 month response assessment 1 month after reirradiation
Safety and Tolerability as Defined as Number of Patients With Adverse Events day 1-12 Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events
Ketosis day 1-12 urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12
Trial Locations
- Locations (2)
Dr. Senckenberg Institute of Neurooncology
🇩🇪Frankfurt, Germany
University of Tuebingen
🇩🇪Tuebingen, Germany
Dr. Senckenberg Institute of Neurooncology🇩🇪Frankfurt, Germany