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The purpose of this research study is to see if people can produce ketones in their blood with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your blood by restricting carbohydrates to <20 grams per day. Ketones are substances that are produced in the blood when fat is being broken down. Ketones may help radiation work better and may starve your tumor because it is thought that some brain tumors can not use ketones to grow and can only use sugar or glucose to grow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Atkins Ketogenic Diet | Experimental | Modified Atkins Ketogenic Diet in combination with Temodar and Radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Atkins Ketogenic Diet | Other | Less than 20 grams of carbohydrates per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ketosis | Ketosis measured by serum beta-hydroxybuterate. Ketosis is defined as having serum beta-hydroxybuterate (BHB) at > 0.05 mM. Participants' BHB levels were assessed at 6 weeks after starting the study. The number of participants who had BHB at > 0.05 mM were considered to have entered into ketosis. 9 of 9 participants met this criteria. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progression Free Survival | Progression Free Survival (PFS) is defined as the percentage of patients without progression at 6 months. Progression will be evaluated via Radiographic Assessment in Neuro-oncology (RANO) criteria: >5 mm increase in maximal diameter, as well as ≥ 25% increase in the sum of the products of the progressing. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rekha Chaudhary, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Health | Cincinnati | Ohio | 45219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Atkins Ketogenic Diet | Modified Atkins Ketogenic Diet in combination with Temodar and Radiation Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Atkins Ketogenic Diet | Modified Atkins Ketogenic Diet in combination with Temodar and Radiation Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Ketosis | Ketosis measured by serum beta-hydroxybuterate. Ketosis is defined as having serum beta-hydroxybuterate (BHB) at > 0.05 mM. Participants' BHB levels were assessed at 6 weeks after starting the study. The number of participants who had BHB at > 0.05 mM were considered to have entered into ketosis. 9 of 9 participants met this criteria. | Posted | Count of Participants | Participants | 6 weeks |
|
|
Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years
The definitions do not differ from clinicaltrials.gov's definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified Atkins Ketogenic Diet | Modified Atkins Ketogenic Diet in combination with Temodar and Radiation Modified Atkins Ketogenic Diet: Less than 20 grams of carbohydrates per day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rekha Chaudhary, MD, Adjunct-Associate Professor of Medicine | University of Cincinnati Cancer Center | 513-558-2119 | Rekha.chaudhary@uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2020 | Dec 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| Assessment of Survival | 2 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Progression Free Survival | Progression Free Survival (PFS) is defined as the percentage of patients without progression at 6 months. Progression will be evaluated via Radiographic Assessment in Neuro-oncology (RANO) criteria: >5 mm increase in maximal diameter, as well as ≥ 25% increase in the sum of the products of the progressing. | Posted | Count of Participants | Participants | 6 months |
|
|
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| Secondary | Assessment of Survival | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 3 |
| 9 |
| 6 |
| 9 |
| 9 |
| 9 |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection with unknown ANC - Wound | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Investigations, please specify | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphatics - Other (Specify, __) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Auditory/Ear - Other (Specify, __) | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema: head and neck | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema: limb | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearing | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Irritability | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) - Facial | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) - Ocular | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neurology - Other (Specify, __) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral cavity-gums (gingivitis) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Head/headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Photosensitivity | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash: dermatitis associated with radiation - Chemoradiation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin (cellulitis) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope (fainting) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syndromes - Other (Specify, __) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract NOS | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Vision-blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |