Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will place patients on a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption. Dietitians will provide guidance and teaching of the diet, as well as, monitoring and diet adjustment to ensure metabolic ketosis. Dietitians and study physicians (and their staff) will monitor subjects for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic diet+radiation+temozolomide | Experimental | Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic Diet | Other | A 4-month ketogenic diet will be supervised and monitored by the study investigators. Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining metabolic ketosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the intervention | Proportion of participants experiencing a 10% decrease in weight or body mass index AND have a BMI <18.5 within one month from initiation of the ketogenic diet. | Four Months |
| Safety of the intervention | Number of related adverse events based on CTCAE v.5. | Four months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention | Proportion of enrolled patients able to maintain blood ketone levels >0.3 mM for over 50% of days on study starting 2 weeks after initiation of the ketogenic diet. | Four Months |
| Overall Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jethro Hu, MD | Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Single arm, prospective cohort
Not provided
Not provided
Not provided
Not provided
| Standard-of-care radiation | Radiation | Patients will receive standard-of-care radiation. Radiation is not protocol directed. |
|
| Standard-of-care Temozolomide | Drug | Patients will receive standard-of-care temozolomide. Temozolomide is not protocol directed. |
|
Time (in months) from initiation of the ketogenic diet to date of death
| Sixty months |
| Time-to-progression | Time (in months) from baseline to progressive disease over study duration (estimated 4 months) - measured by RANO criteria (standard of care brain MRI) | Four Months |
| Quality of Life (two months) | Mean change in overall Quality of Life from baseline to two months. -Quality of Life measured using EORTC QLQ-C30 global score | Two months |
| Quality of Life (four months) | Mean change in overall Quality of Life from baseline to four months. -Quality of Life measured using EORTC QLQ-C30 global score | Four months |
| Cognitive function (Hopkins Verbal Learning Test-Revised) | Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Hopkins Verbal learning Test-Revised | Four months |
| Cognitive function (Trail Making Test) | Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Trail Making Test | Four months |
| Cognitive function (Controlled Word Association Test) | Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Controlled Word Association Test | Four months |
| Cognitive function (Montreal Cognitive Assessment) | Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Montreal Cognitive Assessment | Four months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |