Glioblastoma
Conditions
Keywords
brain tumor
Brief summary
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.
Interventions
OTHERModified Atkins Ketogenic Diet
Less than 20 grams of carbohydrates per day
Sponsors
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed primary malignant glioma, Grade III or IV * No uncontrolled infection or other active malignancy or chronic systemic immune therapy. * ECOG performance status \< 3. * Life expectancy \> three months. * Adequate labs
Exclusion criteria
* Diagnosis of genetic disorder of fat metabolism. * Type 2 diabetes diagnosed with a hemoglobin A1C \> 6.4 * Allergic to dairy or lactose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ketosis | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progression Free Survival | 6 months | 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. |
| Assessment of Survival | 2 years | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Modified Atkins Ketogenic Diet |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 9 |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 6 / 9 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Modified Atkins Ketogenic Diet | Number of Participants With Ketosis | 9 Participants |
Secondary
Assessment of Survival
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Modified Atkins Ketogenic Diet | Assessment of Survival | 6 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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Modified Atkins Ketogenic Diet | Number of Participants With Progression Free Survival | 6 Participants |