Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 11/2/2018 |
| Start Date: | April 2012 |
| End Date: | June 2019 |
This study will look at the effects, good and/or bad, of treating primary brain cancers with
diet therapy using an energy restricted ketogenic diet (ERKD) that uses food. An energy
restricted ketogenic diet is a diet designed to keep blood sugars in the low range of normal
while at the same time increasing the blood concentration of metabolic break down products
called ketones. This diet is currently used to treat children with uncontrollable seizures.
This diet is well tolerated by the children with minimal side effects reported after using
the diet for years.
- The main purpose of this study is to find out whether or not the energy restricted
ketogenic diet will help patients with primary brain cancer by either decreasing the
size of the cancer or by keeping the cancer from growing.
- Another reason for doing this study is to learn about the side effects associated with
the energy restricted ketogenic diet in patients with primary brain cancer.
diet therapy using an energy restricted ketogenic diet (ERKD) that uses food. An energy
restricted ketogenic diet is a diet designed to keep blood sugars in the low range of normal
while at the same time increasing the blood concentration of metabolic break down products
called ketones. This diet is currently used to treat children with uncontrollable seizures.
This diet is well tolerated by the children with minimal side effects reported after using
the diet for years.
- The main purpose of this study is to find out whether or not the energy restricted
ketogenic diet will help patients with primary brain cancer by either decreasing the
size of the cancer or by keeping the cancer from growing.
- Another reason for doing this study is to learn about the side effects associated with
the energy restricted ketogenic diet in patients with primary brain cancer.
Summary: The current standard of care for glioblastoma multiforme (GBM), the most common
primary brain tumor in adults, includes surgical resection, radiation and chemotherapy.
Survival rarely exceeds 18 months. The investigators propose to test the hypothesis that
brain tumor cells are unable to utilize ketones as a source of energy when deprived of
glucose, due to mitochondrial dysfunction, whereas normal glia and neurons can survive this
metabolic stress. A nutritionally adequate but energy restricted, ketogenic diet (ERKD) to
deprive brain tumors of energy and resulting in death of glioma cells is promising.
ERKD-based therapy to manage brain cancer is both biologically plausible and supported by
data in animal models. A multidisciplinary team of oncologists, registered dietitians, and
physiologists will implement an ERKD therapy in newly diagnosed GBM subjects. After initial
maximal tumor excision, ERKD therapy will be initiated for subjects during a one week
inpatient admission to Sparrow Hospital or as a local outpatient and supervised by registered
dietitians experienced in implementing this therapy.The ERKD will continue as adjunctive
therapy along with radiation therapy and standard of care chemotherapy. The supervised ERKD
will continue for an additional 6 weeks after completion of radiation therapy along with the
standard of care chemotherapy. The objective of this trial is to determine whether the ERKD
decreases tumor size or results in no recurrence in individuals with GBM as measured by
serial MRI imaging. Enzymes and signaling pathways that regulate metabolism and cell growth
will be assessed in initial and post-ERKD tumors using standard biochemical approaches.
primary brain tumor in adults, includes surgical resection, radiation and chemotherapy.
Survival rarely exceeds 18 months. The investigators propose to test the hypothesis that
brain tumor cells are unable to utilize ketones as a source of energy when deprived of
glucose, due to mitochondrial dysfunction, whereas normal glia and neurons can survive this
metabolic stress. A nutritionally adequate but energy restricted, ketogenic diet (ERKD) to
deprive brain tumors of energy and resulting in death of glioma cells is promising.
ERKD-based therapy to manage brain cancer is both biologically plausible and supported by
data in animal models. A multidisciplinary team of oncologists, registered dietitians, and
physiologists will implement an ERKD therapy in newly diagnosed GBM subjects. After initial
maximal tumor excision, ERKD therapy will be initiated for subjects during a one week
inpatient admission to Sparrow Hospital or as a local outpatient and supervised by registered
dietitians experienced in implementing this therapy.The ERKD will continue as adjunctive
therapy along with radiation therapy and standard of care chemotherapy. The supervised ERKD
will continue for an additional 6 weeks after completion of radiation therapy along with the
standard of care chemotherapy. The objective of this trial is to determine whether the ERKD
decreases tumor size or results in no recurrence in individuals with GBM as measured by
serial MRI imaging. Enzymes and signaling pathways that regulate metabolism and cell growth
will be assessed in initial and post-ERKD tumors using standard biochemical approaches.
- Inclusion Criteria:
- Adult subjects over age 18 with biopsy proven GBM diagnosis
- Measurable disease after standard therapies
- Eastern Cancer Oncology Group performance status < or =2; and
- Life expectancy >3 months.
Exclusion Criteria:
- Diagnosis of diabetes mellitus that is being treated by medication
- Concomitant use of glucocorticosteroids
- Cholecystectomy within 1 year prior to study entry
- Inability to adhere to or tolerate dietary protocol
- Active malignancy other than primary brain tumor requiring therapy
- Participation in an investigational study within 2 weeks prior to study entry; Major
co-morbidities such as liver, kidney or heart failure that in the judgment of the
investigators would disqualify the subject from the trial
- Pregnancy
- Inability to give informed consent
We found this trial at
1
site
East Lansing, Michigan 48824
Principal Investigator: Ken A Schwartz, MD
Phone: 517-775-8660
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