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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01865162 | Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study | PHASE1 | COMPLETED | 6 | — | — | Jan 1, 2013 | Jan 1, 2021 | Nov 9, 2022 | 1 | United States |
Early treatment discontinuation, treatment compliance, 7-point Licker hunger scale, fasting lipid levels and fasting serum glucose and insulin levels
| Arm | Type | Description |
|---|---|---|
| ketogenic diet | EXPERIMENTAL | Treatment will consist of ketogenic diet. KD will consist of 4:1 \[fat\] : \[protein+carbohydrate\] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard. |
| 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. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard. |
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 recurrence or progression after surgical resection/debulking, radiation and temozolamide chemother...