Clinical trial NCT01754350: Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma
Official title: Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Glioblastoma
Keywords: ketogenic diet
glioma
fasting
reirradiation
nutrition
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Tavarlin
First posted: 2012-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free-survival
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9
timeFrame: day 1-12
measure: Safety and Tolerability as Defined as Number of Patients With Adverse Events
timeFrame: day 1-12
measure: Progression-free-survival
timeFrame: 1 month, 3 months
measure: Overall Survival
timeFrame: 12 months
measure: Frequency of Seizures
timeFrame: day 1-12
measure: Ketosis
timeFrame: day 1-12
measure: Quality of Life as Measured by the EORTC Quality of Life Questionnaire
timeFrame: day 1-12
measure: Depression
timeFrame: day 1-12
measure: Attention
timeFrame: day 1-12
measure: Response
timeFrame: 1 month
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Dr. Senckenberg Institute of Neurooncology
city: Tuebingen
country: Germany
facility: University of Tuebingen
Study officials:
References:
citation: Voss M, Wenger KJ, von Mettenheim N, Bojunga J, Vetter M, Diehl B, Franz K, Gerlach R, Ronellenfitsch MW, Harter PN, Hattingen E, Steinbach JP, Rodel C, Rieger J. Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. Eur J Nutr. 2022 Feb;61(1):477-487. doi: 10.1007/s00394-021-02666-1. Epub 2021 Sep 6.
citation: Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
citation: Voss M, Wagner M, von Mettenheim N, Harter PN, Wenger KJ, Franz K, Bojunga J, Vetter M, Gerlach R, Glatzel M, Paulsen F, Hattingen E, Baehr O, Ronellenfitsch MW, Fokas E, Imhoff D, Steinbach JP, Rodel C, Rieger J. ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):987-995. doi: 10.1016/j.ijrobp.2020.06.021. Epub 2020 Jun 30.