Clinical trial · Interventional
Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma
Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calorie-restricted ketogenic diet and transient fasting | Dietary Supplement | — | UNRESOLVED |
| standard nutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ketogenic diet and transient fasting
- description
- Calorie-restricted, ketogenic diet and transient fasting during reirradiation
- interventionNames
- Dietary Supplement: calorie-restricted ketogenic diet and transient fasting
- type
- ACTIVE_COMPARATOR
- label
- standard nutrition
- description
- nutrition according to recommendations of the German society for nutrition during reirradiation
- interventionNames
- Dietary Supplement: standard nutrition
Primary outcomes (1)
- measure
- Progression-free-survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDVoss 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. PMID 34487222
- DERIVEDAllaf 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. PMID 33512717
- DERIVEDVoss 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. PMID 32619561