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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA276919 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a Phase 2, randomized two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomized 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive standard of care treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians. Daily ketone and glucose levels will be recorded to monitor Keto Diet adherence.
This two-armed randomized multi-site study aims to provide evidence to support the hypothesis that a Keto Diet vs. Standard Anti-Cancer Diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keto-Diet | Experimental | Intensive 18-week Keto Diet intervention. |
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| Standard Anti-Cancer Diet | Placebo Comparator | Standard Anti-Cancer Diet with Dietitian support |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keto Diet | Behavioral | The experimental intervention includes a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Will be calculated as the number of days from the date of patient registration to the date of death. | From Baseline to 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life 1 | Measured by changes in the Functional Assessment of Cancer Therapy - Brain (FACT-BR) survey scores. Scores can range from 0- 200, the higher the score the better the quality of life. | From Baseline to 18 Weeks |
| Health-related quality of life 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Recruitment Navigator | Contact | 3104232133 | GroupCancerTrialInformation@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Jethro Hu, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| Standard Anti-Cancer Diet | Behavioral | Dietitian sessions will utilize the American Institute for Cancer Research Food resources and will reference foods low in fats such as fruits, vegetables and whole grains, providing key micronutrients and phytonutrients. Sessions will also focus on dietary support to help decrease any treatment related symptoms. |
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Measured by changes in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey scores. Scores can range from 0- 160, the higher the score the better the quality of life. |
| From Baseline to 18 Weeks |
| Progression-free survival | Assessed with Magnetic resonance imaging (MRI) scan of the brain with and without gadolinium. MRI's will be reviewed and assessed for progression free survival via the modified Response Assessment in Neuro-Oncology Criteria. | From Baseline to 18 Weeks |
| Cognitive performance 1 | Measured by changes in the Hopkins Verbal Test (HVLT-R) survey scores. Scores can range from 0-36, higher the scores the better the cognitive performance. | From Baseline to 18 Weeks |
| Cognitive performance 2 | Measured by changes in the Trail Marking Test A/B survey scores. The longer the task takes to complete the lower the cognitive performance. | From Baseline to 18 Weeks |
| Physical activity | Measured by changes in the modified Godin leisure questionnaire survey scores. The more minutes per week spent in exercise the better the physical activity. | From Baseline to 18 Weeks |
| Physical activity | Measured by Fitbit data changes. The higher the step count the better the physical activity. | From Baseline to 18 Weeks |
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Pacific Neuroscience Institute / Saint John's Cancer Institute | Recruiting | Santa Monica | California | 90404 | United States |
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| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
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| Medical College of Wisconsin | Withdrawn | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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