Clinical trial · Interventional
Metabolic Therapy Program In Conjunction With Standard Treatment For Glioblastoma
Feasibility, Safety, and Efficacy of a Metabolic Therapy Program in Conjunction With Standard Treatment for Glioblastoma
- 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)
Glioblastoma (GBM), a very aggressive brain tumour, is one of the most malignant of all cancers and is associated with a poor prognosis. The majority of GBM cells display damaged mitochondria (the "batteries" of cells), so they rely on an alternate method for producing energy called the Warburg Effect, which relies nearly exclusively on glucose (in contrast, normal cells can use other molecules, such as fatty acids and fat-derived ketones, for energy). Metabolic interventions, such as fasting and ketogenic diets, target cancer cell metabolism by enhancing mitochondria function, decreasing blood glucose levels, and increasing blood ketone levels, creating an advantage for normal cells but a disadvantage for cancer cells. Preliminary experience at Waikato Hospital has shown that a metabolic therapy program (MTP) utilizing fasting and ketogenic diets is feasible and safe in people with advanced cancer, and may provide a therapeutic benefit. We aim to determine whether using an MTP concurrently with standard oncological treatment (chemoradiation followed by adjuvant chemotherapy) is feasible and safe in patients with GBM, and has treatment outcomes consistent with greater overall treatment efficacy than in published trials.
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 | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Treatment Plus Metabolic Therapy Program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Standard treatment in conjunction with MTP
- description
- Standard: * Concurrent chemoradiation - Radiation (60-Gy in 30 fractions over 6 weeks) with daily oral temozolomide. * Adjuvant chemotherapy - Daily oral temozolomide (5 days per 4-week cycle, starting 4 weeks after completion of chemoradiation, with at least 6 cycles intended). MTP: \- Two 5-day fasts (allowing water, salt, tea, coffee, and a magnesium supplement) during chemoradiation followed by a 5-day fast during each adjuvant chemotherapy cycle, with a time-restricted modified ketogenic diet (one or two 1-hour eating windows per day, allowing oils, meats, vegetables, nuts, seeds, limited berries, and a multivitamin) between fasts.
- interventionNames
- Other: Standard Treatment Plus Metabolic Therapy Program
Primary outcomes (1)
- measure
- Mean daily blood glucose-to-ketone ratio during chemoradiation
- timeFrame
- 9 weeks
- description
- Proportion of patients able to sustain functional ketosis (defined as a mean daily blood glucose-to-ketone ratio of ≤6) during chemoradiation (defined as the beginning of the first fast through to 3 weeks following completion of chemoradiation)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or greater. 2. Newly-diagnosed histologically-confirmed GBM. 3. ECOG Performance Status 0-2. 4. Planned for 6 weeks of standard chemoradiation for GBM. 5. If receiving dexamethasone, the dose must be ≤ 4 mg daily (and not increasing) upon commencement of the MTP. Exclusion Criteria: 1. Ineligible for standard treatment for GBM due to poor performance status, co-morbidities, or inability to give informed consent. 2. Type 1 diabetes. 3. A medical or psychiatric disorder that, in the opinion of the investigators, would make it unlikely that the patient could adhere to the MTP.
References
Publications (1)
- BACKGROUNDPhillips MCL, Thotathil Z, Haji Mohd Yasin NAB, de Groot C, Tan A, Kuper-Hommel M, Creagh LA, Ji E, Naidoo N, van Essen M, Ziad F, Moon BG, Frampton C, Jameson MB. Intensive multimodal ketogenic metabolic therapy in glioblastoma: A clinical trial. Neurooncol Adv. 2026 Jun 29;8(1):vdag165. doi: 10.1093/noajnl/vdag165. eCollection 2026 Jan-Dec. PMID 42542667