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Ketogenic Diet, Standardized Diet · 1 trial · 1 indication
We hope to achieve a substantial difference in both survival time and time to recurrence between the KD and non-KD treatment groups. Survival time of 3 years from treatment initiation and tumor progression-free time of 2.5 years from treatment initiation would be extraordinary compared to historical data.
MRI outcome will be assessed by the radiographic assessment in neuro-oncology criteria based on contrast-enhanced cranial MRI scans evaluating measureable disease, measured as the sum of products of perpendicular diameters (bi-dimensional measurements) of all measurable enhancing lesions and non-measurable disease.
Incidence of treatment-emergent adverse events changes in laboratory evaluations, changes in physical examination findings will be compared between the KD and control treatment groups
| Arm | Type | Description |
|---|---|---|
| Ketogenic Diet | ACTIVE_COMPARATOR | Treatment will consist of ketogenic diet. KGD will consist of 4:1 \[fat\] : \[protein+carbohydrate\] weight ratio with 1600 kcal restriction. Diet will be started at the time of initiation of radiation treatment. |
| Standardized diet | OTHER | The subjects will be taken standard diet in a 1:1 ratio. |
| Name | Type | Description |
|---|---|---|
| Ketogenic Diet | OTHER | Treatment will consist of ketogenic diet. KD will consist of 4:1 \[fat\] : \[protein+carbohydrate\] weight ratio with 1600 kcal restriction. |
| Standardized Diet | OTHER | Participants with GBM treated with radiation and temozolomide after surgical debulking treatment. The subjects will be taken standard diet in a 1:1 ratio. Diet will be started at the time of initiation of radiation treatment. |
Inclusion Criteria: 1. Age 18-65 2. Ability and willingness to signed informed consent form 3. Astrocytoma grade 4 (glioblastoma multiforme, GBM, histologically confirmed, WHO criteria) 4. Documented surgical resection/debulking 5. Measurable contrast-enhancing GBM by MRI imaging ≤ two weeks before...
Ketogenic Diet, Standardized Diet is an investigational dietary intervention being studied as an adjunctive treatment for Glioblastoma Multiforme, a type of brain cancer. It is being evaluated in clinical trials to assess its potential role alongside standard therapies such as radiation and chemotherapy for this condition.
Ketogenic Diet, Standardized Diet is being developed by Atlantic International Corp., a company traded under the ticker symbol ATLN. The company is conducting clinical research to evaluate this dietary approach in the context of glioblastoma multiforme treatment.
Ketogenic Diet, Standardized Diet is currently in Phase 2 clinical development for glioblastoma multiforme. It remains an investigational dietary intervention and has not been approved by regulatory authorities. Its clinical program includes completed trials that have evaluated its safety and feasibility.
Ketogenic Diet, Standardized Diet has been studied in two completed clinical trials. NCT01865162 was a Phase 1 pilot study in refractory or end-stage glioblastoma multiforme with 6 participants. NCT02302235 was a Phase 2 pilot study testing the diet as an adjunct to radiation and chemotherapy in glioblastoma multiforme, enrolling 42 participants.
Ketogenic Diet, Standardized Diet refers to a specific standardized formulation of a ketogenic diet being investigated as a therapeutic intervention. It is distinct from general dietary recommendations, as it is being developed and studied in a controlled clinical setting for its potential effects on glioblastoma multiforme.