Glioblastoma Multiforme
Conditions
Keywords
ketogenic diet, recurrent glioblastoma, chemotherapy
Brief summary
Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro. Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma.
Detailed description
Diet change by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and inhibit tumor growth. In a pilot of recurrent glioblastoma, ketogenic diet adjuvant salvage chemotherapy was given as interventional group and standard diet adjuvant salvage chemotherapy was given as control group. The study examines whether a ketogenic diet adjunctive to salvage chemotherapy can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.
Interventions
DIETARY_SUPPLEMENTKetogenic diet
Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
DIETARY_SUPPLEMENTStandard diet
Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
Sponsors
Song Lin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-60 2. Karnovsky Performance Score of 60 or more. 3. histologically confirmed glioblastoma multiforme, grade 4 4. Ability and willingness to signed informed consent form. 5. Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy. 6. normal function of liver and kidney
Exclusion criteria
1. Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis 2. History of uncontrolled hyperlipidemia or hyperglycemia. 3. History of human immunodeficiency virus, or hepatitis C 4. Pregnancy or breastfeeding 5. Inability or unwillingness of subject to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Effects | one year | Number of participants with treatment-emergent adverse effects while on ketogenic diet. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Chemosensitivity of Tumor | one year | MRI(Magnetic Resonance Imaging) will be used to measure changes in brain tumor size (cm\^2). |
| Overall Survival | one year | Participants were followed until reported death |
| Ketosis | one year | Urine and blood ketosis (mmol/L) were measured |
| Quality of Life | one year | quality of life measured by the Karnofsky Performance Scale |
Countries
China
Contacts
Primary ContactSong Lin, M.D.,
Backup ContactXiaohui Ren, M.D.,
Outcome results
None listed