Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

St. Joseph's Hospital and Medical Center, Phoenix

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Glioblastoma (GBM)

Treatments: Radiation: Radiation therapy; Dietary Supplement: Ketogenic Diet; Drug: Temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02046187

KD-13BN069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Ketogenic Diet

Experimental group

Description:

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.

Treatment:

Drug: Temozolomide

Radiation: Radiation therapy

Dietary Supplement: Ketogenic Diet