Clinical trial · Interventional
Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma
Phase I/II Prospective Trial for Newly Diagnosed GBM, With Upfront Gross or Subtotal Resection, Followed by Ketogenic Diet With Radiotherapy and Concurrent Temodar(R) Chemotherapy Followed by Adjuvant Temodar(R) Chemotherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): excessive protocol deviations due to strict nature of diet requirements
Summary
Brief summary (as posted)
This study aims to see if reducing blood sugar and increasing ketones (a metabolic product that comes from using fats for energy) can increase survival and enhance the the effects of standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM). These changes occur from use of a ketogenic diet. This research has 2 goals: 1. Show that patients can tolerate the diet and maintain low blood glucose and high blood ketone levels. 2. Show if this diet enhances the effectiveness of standard treatment by prolonging survival of patients with a GBM.
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 |
|---|---|---|---|
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketogenic Diet | Dietary Supplement | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ketogenic Diet
- description
- Subjects will adhere to a ketogenic diet prior to the start of and through radiation therapy course until the time of first scan after radiation ends. During radiation course, patients also take temozolomide daily.
- interventionNames
- Dietary Supplement: Ketogenic Diet
- Radiation: Radiation therapy
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- 8 weeks
- description
- Number of participants with adverse events from initiation of ketogenic diet through end of radiation (while on ketogenic diet)
Secondary outcomes (3)
- measure
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, 18 - 80 years of age, * a single enhancing lesion of the brain with MRI appearance consistent with GBM * Pathologic confirmation of GBM * Zubrod Performance Scale (ZPS) \< 2 * Must be able to undergo MRI imaging with gadolinium * Must have access to a computer and the internet (to use KetoCalculator© on-line Database) Exclusion Criteria: * unable to undergo MRI with gadolinium * genetic disorders of fat metabolism * patients receiving sodium valproate (may cause false ketone reading in urine) * diabetes * enrolled in another treatment trial for GBM
References
Publications (3)
- BACKGROUNDAbdelwahab MG, Fenton KE, Preul MC, Rho JM, Lynch A, Stafford P, Scheck AC. The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. PLoS One. 2012;7(5):e36197. doi: 10.1371/journal.pone.0036197. Epub 2012 May 1. PMID 22563484
- BACKGROUNDScheck AC, Abdelwahab MG, Fenton KE, Stafford P. The ketogenic diet for the treatment of glioma: insights from genetic profiling. Epilepsy Res. 2012 Jul;100(3):327-37. doi: 10.1016/j.eplepsyres.2011.09.022. Epub 2011 Oct 22. PMID 22019313
- BACKGROUNDStafford P, Abdelwahab MG, Kim DY, Preul MC, Rho JM, Scheck AC. The ketogenic diet reverses gene expression patterns and reduces reactive oxygen species levels when used as an adjuvant therapy for glioma. Nutr Metab (Lond). 2010 Sep 10;7:74. doi: 10.1186/1743-7075-7-74. PMID 20831808