Clinical trial · Interventional
A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases
A "Classic" Ketogenic Diet as a Complementary Therapeutic Management on Patients With High-grade Gliomas and Brain Metastases.
NCT05564949CI-TRIAL-00090440recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The survival interval of patients with gliomas ranges between 12 to 15 months. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. Ketosis can be an effective therapy to extend the survival of patients with gliomas.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CKD | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Classic Ketogenic Diet
- description
- Patients will adhere to a classic ketogenic diet for a period of 3 months with a possible extension depending on their compliance on the diet.
- interventionNames
- Other: CKD
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Participants will be followed from date of randomization until the date of death from any cause, assessed up to 36 months.
Secondary outcomes (4)
- measure
- Changes in brain tumor size
- timeFrame
- 2 years, Baseline, 3, 6, 12, and 24 months
- description
- MRI (Magnetic Resonance Imaging) will be used to measure changes in tumor size (cm\^2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80 * Karnofsky Performance Score of 50 or more. * Newly diagnosed, histologically confirmed glioblastoma grade 4, or secondary metastases or progression after surgical resection, radiation and chemotherapy. * Normal function of liver and kidneys * Ability to sign informed consent form Exclusion Criteria: * Diabetes mellitus * Life expectancy \>3 months * Inability to adhere to diet * Inability to give informed consent form * Cholecystectomy last 1 year (before the study entry) * Diagnosis of genetic disorder of fat metabolism
References
Publications (4)
- BACKGROUNDThomas JG, Veznedaroglu E. Ketogenic Diet for Malignant Gliomas: a Review. Curr Nutr Rep. 2020 Sep;9(3):258-263. doi: 10.1007/s13668-020-00332-2. PMID 32720120
- BACKGROUNDSargaco B, Oliveira PA, Antunes ML, Moreira AC. Effects of the Ketogenic Diet in the Treatment of Gliomas: A Systematic Review. Nutrients. 2022 Feb 27;14(5):1007. doi: 10.3390/nu14051007. PMID 35267981
- BACKGROUNDEbrahimpour-Koujan S, Shayanfar M, Benisi-Kohansal S, Mohammad-Shirazi M, Sharifi G, Esmaillzadeh A. Adherence to low carbohydrate diet in relation to glioma: A case-control study. Clin Nutr. 2019 Dec;38(6):2690-2695. doi: 10.1016/j.clnu.2018.11.023. Epub 2018 Nov 30. PMID 30551899
- BACKGROUNDPerry A, Wesseling P. Histologic classification of gliomas. Handb Clin Neurol. 2016;134:71-95. doi: 10.1016/B978-0-12-802997-8.00005-0. PMID 26948349