Glioblastoma Clinical Trial
Official title:
Feasibility, Safety, and Efficacy of a Metabolic Therapy Program in Conjunction With Standard Treatment for Glioblastoma
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.
Status | Recruiting |
Enrollment | 22 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
New Zealand | Waikato Hospital | Hamilton | Waikato |
Lead Sponsor | Collaborator |
---|---|
Waikato Hospital | Wellington Hospital |
New Zealand,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Mean daily blood glucose-to-ketone ratio during adjuvant chemotherapy | Proportion of patients able to sustain functional ketosis during adjuvant chemotherapy (defined as the beginning of the first adjuvant chemotherapy fast through to completion of adjuvant chemotherapy) | 24 weeks | |
Secondary | Mean daily blood glucose-to-ketone ratio during the MTP, calculated separately on fasting and ketogenic diet days | Proportion of patients able to sustain functional ketosis during the MTP (defined as the beginning of chemoradiation through to the end of adjuvant chemotherapy), calculated separately each fasting and ketogenic diet phase | 33 weeks | |
Secondary | Change in weight | Weight (kg) | 33 weeks | |
Secondary | Safety as measured by National Cancer Institute Common Terminology Criteria for Adverse Events (version 4) | Number of adverse events (of any grade) | 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 | |
Secondary | Change in performance status as measured by Eastern Cooperative Oncology Group Performance Status scale | Eastern Cooperative Oncology Group Performance Status scale (scores range from 0 to 5, with higher scores indicating lower performance status) | 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 | |
Secondary | Change in leisure/exercise activity as measured by Godin Leisure-Time Exercise questionnaire | Godin Leisure-Time Exercise questionnaire (scores range from 0 to no maximum, with higher scores indicating higher leisure/exercise activity) | 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 | |
Secondary | Change in quality of life as measured by Functional Assessment of Cancer Therapy - Brain questionnaire | Functional Assessment of Cancer Therapy - Brain questionnaire (scores range from 0 to 200, with higher scores indicating higher quality of life) | 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 | |
Secondary | Progression-free survival | Progression-free survival | From date of biopsy-confirmed diagnosis to date of first documented progression, whichever came first, up to 33 weeks | |
Secondary | Overall survival | Overall survival | From date of biopsy-confirmed diagnosis to date of death from any cause, whichever came first, up to 33 weeks |
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