Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma

Johann Wolfgang Goethe University Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Glioblastoma

Interventions

calorie-restricted ketogenic diet and transient fasting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (2)

Dr. Senckenberg Institute of Neurooncology

Frankfurt, Germany

University of Tuebingen

Tübingen, Germany

Outcomes

Primary Outcomes

Progression-free-survival

Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)

Time frame: 6 months

Secondary Outcomes

Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9

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

Time frame: day 1-12

Safety and Tolerability as Defined as Number of Patients With Adverse Events

Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events

Time frame: day 1-12

Progression-free-survival

progression-free-survival rates 1 month and 3 month after reirradiation

Time frame: 1 month, 3 months

Overall Survival

overall survival after the reirradiation

Time frame: 12 months

Frequency of Seizures

frequency of seizures at day 1-12

Time frame: day 1-12

Ketosis

urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12

Time frame: day 1-12

Quality of Life as Measured by the EORTC Quality of Life Questionnaire

Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire

Time frame: day 1-12

Depression

depression as measured by SCL-90 at day 1-12

Time frame: day 1-12

Attention

attention as measured by d2-testing at day 1-12

Time frame: day 1-12

Response

response assessment 1 month after reirradiation

Time frame: 1 month