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Trial Title:
Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors
NCT ID:
NCT01535911
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Brain Neoplasms
Conditions: Keywords:
ketogenic diet
brain tumors
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)
Description:
Adult subjects with newly diagnosed glioblastoma will be referred to the study. Residual
tumor size will be determined using MRI imaging. Subjects will be placed on ERKD while
they are being treated with radiation therapy and standard of care chemotherapy. After
completion of radiation therapy, tumor size will be determined using MRI. If the tumor
has decreased in size or remained the same (stable disease), the subjects will be
continued on the ERKD for an additional 6 weeks. Total calories consumed by each subject
will be targeted to 20 to 25 kcal/kg/day. If the tumor has decreased in size or the size
has remained the same then subjects will be continued on the ERKD for as additional 6
weeks and a repeat MRI will be obtained.
Arm group label:
Obsrvational study adding ketogenic diet to standard initial treatment of glioblastom multiforme
Other name:
Ketogenic diet
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Michigan State University/Sparrow Hospital
Address:
City:
East Lansing
Zip:
48824
Country:
United States
Start date:
April 1, 2012
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Michigan State University
Agency class:
Other
Collaborator:
Agency:
Sparrow Health System
Agency class:
Other
Source:
Michigan State University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01535911