An interventional study of Modified Atkins Ketogenic Diet in Glioblastoma, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Other: Modified Atkins Ketogenic Diet
Less than 20 grams of carbohydrates per day
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
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
Assessment of Survival
Time frame: 2 years
| Milestone | Modified Atkins Ketogenic Diet |
|---|---|
| Started | 12 |
| Completed | 9 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 1 |
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.
| Participants | Modified Atkins Ketogenic Diet |
|---|---|
| Number of Participants With Ketosis | 9 |
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.
| Participants | Modified Atkins Ketogenic Diet |
|---|---|
| Number of Participants With Progression Free Survival | 6 |
| Participants | Modified Atkins Ketogenic Diet |
|---|---|
| Assessment of Survival | 6 |
Collected over Adverse Events monitored/assessed for 2-3 months after pre-treatment visit 1, All-Cause Mortality monitored/assessed for up to 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Modified Atkins Ketogenic Diet | 3/9 (33.3%) | 6/9 (66.7%) | 9/9 (100%) |
| Event | Modified Atkins Ketogenic Diet |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 2/9 |
| Memory impairmentNervous system disorders | 1/9 |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lowerMusculoskeletal and connective tissue disorders | 1/9 |
| HydrocephalusNervous system disorders | 1/9 |
| Infection with unknown ANC - WoundInfections and infestations | 1/9 |
| Investigations, please specifyInvestigations | 1/9 |
| Leukocytes (total WBC)Investigations | 1/9 |
| Lymphatics - Other (Specify, __)Blood and lymphatic system disorders | 1/9 |
| Neutrophils/granulocytes (ANC/AGC)Investigations | 1/9 |
| PlateletsInvestigations | 1/9 |
| Event | Modified Atkins Ketogenic Diet |
|---|---|
| FatigueGeneral disorders | 7/9 |
| ConstipationGastrointestinal disorders | 6/9 |
| Rash: dermatitis associated with radiation - ChemoradiationSkin and subcutaneous tissue disorders | 4/9 |
| DiarrheaGastrointestinal disorders | 3/9 |
| DizzinessNervous system disorders | 3/9 |
| NauseaGastrointestinal disorders | 3/9 |
| AnxietyPsychiatric disorders | 2/9 |
| BruisingInjury, poisoning and procedural complications | 2/9 |
| Edema: limbGeneral disorders | 2/9 |
| Hair loss/alopecia (scalp or body)Skin and subcutaneous tissue disorders | 2/9 |
| Age, Categorical(Participants) | Modified Atkins Ketogenic Diet |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | Modified Atkins Ketogenic Diet |
|---|---|
| Female | 6 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Modified Atkins Ketogenic Diet |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Modified Atkins Ketogenic Diet |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Modified Atkins Ketogenic Diet |
|---|---|
| United States | 9 |
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