Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | September 2016 |
Phase I/II Prospective Trial for Newly Diagnosed GBM, With Upfront Gross or Subtotal Resection, Followed by Ketogenic Diet With Radiotherapy and Concurrent Temodar(R) Chemotherapy Followed by Adjuvant Temodar(R) Chemotherapy.
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.
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.
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.
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.
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
We found this trial at
1
site
Phoenix, Arizona 85013
Principal Investigator: Lynn S Ashby, MD
Phone: 602-406-6267
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