Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma
- Conditions
- Glioblastoma (GBM)
- Interventions
- Registration Number
- NCT02046187
- Lead Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Brief Summary
This study aims to see if reducing blood sugar and increasing ketones (a metabolic product that comes from using fats for energy) can increase survival and enhance the the effects of standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM). These changes occur from use of a ketogenic diet. This research has 2 goals:
1. Show that patients can tolerate the diet and maintain low blood glucose and high blood ketone levels.
2. Show if this diet enhances the effectiveness of standard treatment by prolonging survival of patients with a GBM.
- Detailed Description
The investigators propose to offer this study to patients with newly diagnosed glioblastoma multiforme (GBM) that undergo gross total resection (GTR) or subtotal resection (STR) of their tumor. Post-operatively, these patients and their families will be instructed in the implementation of the Ketogenic Diet (KD) and it will be started as soon as possible following surgery to achieve ketosis and reduction of blood sugar. Patients will receive standard chemoradiotherapy with fractionated external beam radiation (60Gy) and concurrent oral temozolomide chemotherapy followed by 12 adjuvant cycles of temozolomide chemotherapy on a standard dose schedule. Outcome measures of the study group will be compared to historic controls in the treatment arm from the European Organization for Research and Treatment of Cancer (EORTC) temozolomide study published by Roger Stupp et al, New England Journal of Medicine, March 10, 2005.
Note: Gross Total Resection (GTR), Subtotal Resection (STR), temozolomide (Temodar), and radiation therapy are routine care for GBM and are not an investigational component of this study.
Study end-points:
Primary: Ketogenic diet (KD) tolerance and compliance in brain tumor patients. The diet will be considered tolerable if the patient chooses to remain compliant. Compliance is monitored by the dietician using self reporting of diet, blood glucose and blood ketone levels.
Secondary: Overall survival, time to recurrence, health and therapy-related quality of life. Overall survival and progression free survival will be measured and compared to the historic controls who received chemoradiotherapy in standard dose scheduling.
Laboratory correlate: Molecular/immunohistochemical analysis of tumors that do and do not respond to a KD.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- adult patients, 18 - 80 years of age,
- a single enhancing lesion of the brain with MRI appearance consistent with GBM
- Pathologic confirmation of GBM
- Zubrod Performance Scale (ZPS) < 2
- Must be able to undergo MRI imaging with gadolinium
- Must have access to a computer and the internet (to use KetoCalculator© on-line Database)
- unable to undergo MRI with gadolinium
- genetic disorders of fat metabolism
- patients receiving sodium valproate (may cause false ketone reading in urine)
- diabetes
- enrolled in another treatment trial for GBM
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ketogenic Diet Ketogenic Diet Subjects will adhere to a ketogenic diet prior to the start of and through radiation therapy course until the time of first scan after radiation ends. During radiation course, patients also take temozolomide daily. Ketogenic Diet Radiation therapy Subjects will adhere to a ketogenic diet prior to the start of and through radiation therapy course until the time of first scan after radiation ends. During radiation course, patients also take temozolomide daily. Ketogenic Diet Temozolomide Subjects will adhere to a ketogenic diet prior to the start of and through radiation therapy course until the time of first scan after radiation ends. During radiation course, patients also take temozolomide daily.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events 8 weeks Number of participants with adverse events from initiation of ketogenic diet through end of radiation (while on ketogenic diet)
- Secondary Outcome Measures
Name Time Method overall survival 2 years overall survival
time to progression 2 years time to progression
quality of life 2 years patient reported outcome of their quality of life using FACT-BR (version 4) survey
Trial Locations
- Locations (1)
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States