Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02302235 | Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study | PHASE2 | COMPLETED | 42 | — | — | Feb 1, 2014 | May 1, 2022 | Aug 11, 2022 | 1 | United States |
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...