Metabolic Therapy Program In Conjunction With Standard Treatment For Glioblastoma

NCT04730869 | Completed

• 3 other identifiers: RD020132U1111-1262-0203Grant #321
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Glioblastoma

Keywords

cancer; glioblastoma; metabolic therapy; fasting; ketogenic diet

Outcome Measures

Primary Outcomes (1)

• Mean daily blood glucose-to-ketone ratio during chemoradiation

  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)

  9 weeks

Secondary Outcomes (9)

• Mean daily blood glucose-to-ketone ratio during adjuvant chemotherapy

  24 weeks

• Mean daily blood glucose-to-ketone ratio during the MTP, calculated separately on fasting and ketogenic diet days

  33 weeks

• Change in weight

  33 weeks

• Safety as measured by National Cancer Institute Common Terminology Criteria for Adverse Events (version 4)

  After each week (7 days) during chemoradiation, then after cycle 1 (28 days) of adjuvant chemotherapy, then after every 2 cycles (56 days) of adjuvant chemotherapy

• Change in performance status as measured by Eastern Cooperative Oncology Group Performance Status scale

  After each week (7 days) during chemoradiation, then after cycle 1 (28 days) of adjuvant chemotherapy, then after every 2 cycles (56 days) of adjuvant chemotherapy

Study Arms (1)

Standard treatment in conjunction with MTP

EXPERIMENTAL

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.

Other: Standard Treatment Plus Metabolic Therapy Program

Interventions

Standard Treatment Plus Metabolic Therapy Program OTHER

See description under "Arms."

Standard treatment in conjunction with MTP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or greater.
• Newly-diagnosed histologically-confirmed GBM.
• ECOG Performance Status 0-2.
• Planned for 6 weeks of standard chemoradiation for GBM.
• If receiving dexamethasone, the dose must be ≤ 4 mg daily (and not increasing) upon commencement of the MTP.

You may not qualify if:

• Ineligible for standard treatment for GBM due to poor performance status, co-morbidities, or inability to give informed consent.
• Type 1 diabetes.
• A medical or psychiatric disorder that, in the opinion of the investigators, would make it unlikely that the patient could adhere to the MTP.

Sponsors & Collaborators

• Wellington Hospital: collaborator
• Waikato Hospital: lead

Study Sites (1)

Waikato Hospital

Hamilton, Waikato Region, 3204, New Zealand

Location

MeSH Terms

Conditions

Glioblastoma; Neoplasms; Fasting

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Feeding Behavior; Behavior

Study Officials

• Matthew CL Phillips, FRACP

  Waikato Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 29, 2021
• Study Start: May 26, 2021
• Primary Completion: February 18, 2025
• Study Completion: April 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting immediately upon publication.
• Access Criteria: Upon reasonable request for research purposes.

Locations

NZ (1)