Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT02768389|
Recruitment Status : Recruiting
First Posted : May 11, 2016
Last Update Posted : September 24, 2018
Patients may participate in this research study if they have glioblastoma. (a brain tumor) that has come back after being treated. Standard treatment for this cancer is a chemotherapy drug called bevacizumab. This research study involves bevacizumab in combination with a special diet called the Modified Atkins Diet (MAD).
The purpose of this study is to research if patients can stay on the MAD when it is added to the standard bevacizumab treatment.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Brain Tumor||Drug: Bevacizumab Behavioral: Modified Atkins Diet||Early Phase 1|
- Determine compliance to treatment at 6 and 12 weeks. Compliance is assessed by review of the daily food diary and the urine and serum ketone levels. Diet compliance is defined as following the diet guidelines 80% of the time with resultant ketosis 80% of the time. If 60% of the patients are compliant with the diet, as defined above, that is a considered a positive result.
- Determine patient compliance in monitoring of blood glucose and urine levels of ketosis.
- Determine obstacles to compliance.
- Determine the frequency of achieving ketosis, as measured by urine ketones checked daily and serum BHB checked every two weeks.
- Determine quality of life (FACT-BR) and adverse events.
- Determine response, progression free survival at 6 months (PFS 6), and overall survival (OS).
- To correlate levels of ketosis and blood sugar with treatment outcome.
- To correlate the level of MCT4 expression and IDH1 mutation status with treatment outcome.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma|
|Actual Study Start Date :||September 6, 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Modified Atkins Diet and Bevacizumab
Patients and caregivers will be educated by a nutritionist skilled in the MAD. Patients will also be receiving Bevacizumab as standard of care.
Subjects receive Bevacizumab as standard of care
Behavioral: Modified Atkins Diet
The modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (< 20gm/day).
Other Name: MAD
- Number of subjects following Modified Atkins Diet [ Time Frame: Up to 12 weeks ]The number of patients following a Modified Atkins Diet for at least 80% of the time as a measure of feasibility
- Number of subjects with ketosis [ Time Frame: Up to 12 weeks ]The number of patients with documented ketosis (Serum beta-hydroxybutyrate (BHB) above 4mg/L) for at least 80% of the time as a measure of feasibility
- Correlation of blood sugar levels by compliance level [ Time Frame: Up to 12 weeks ]Correlate the relationship between blood sugar levels and measured level of compliance
- Correlation of ketosis values by compliance level [ Time Frame: Up to 12 weeks ]Correlate the relationship between ketosis values and measured level of compliance
- Correlation of ketosis values by tumor response [ Time Frame: Up to 12 weeks ]Correlate the relationship between ketosis values and measured level of tumor response as a measure of treatment outcomes
- Correlation of blood sugar levels by tumor response [ Time Frame: Up to 12 weeks ]Correlate the relationship between blood sugar levels and measured level of tumor response as a measure of treatment outcomes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768389
|Contact: Lisa Rogers, DO||216-844-3717||Lisa.Rogers1@uhhospitals.org|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: Rekha Chaudhary, MD 513-558-2199 firstname.lastname@example.org|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Lisa Rogers, DO 216-844-3717 Lisa.Rogers1@uhhospitals.org|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: David Peereboom, MD 216-445-6068 email@example.com|
|OhioHealth Research and Innovation Institute||Recruiting|
|Columbus, Ohio, United States, 43214|
|Contact: Mohamed Hamza, MD 614-566-1250 firstname.lastname@example.org|
|Principal Investigator: Mohamed Hamza, MD|
|Principal Investigator:||Lisa Rogers, DO||University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|