Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Dietary Supplement: Ketogenic diet
* Dietary Supplement: Standard diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60 Karnovsky Performance Score of 60 or more. histologically confirmed glioblastoma multiforme, grade 4 Ability and willingness to signed informed consent form. Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy. normal function of liver and kidney Exclusion Criteria: 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 History of uncontrolled hyperlipidemia or hyperglycemia. History of human immunodeficiency virus, or hepatitis C Pregnancy or breastfeeding Inability or unwillingness of subject to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketogenic diet group<br>Ketogenic diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were kept more than 2mmol/L during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded. | Dietary Supplement: Ketogenic diet<br>* Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.<br>|
| Other: Standard diet group<br>Standard diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were recorded during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded. | Dietary Supplement: Standard diet<br>* Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment-emergent Adverse Effects | Number of participants with treatment-emergent adverse effects while on ketogenic diet. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Chemosensitivity of Tumor | MRI(Magnetic Resonance Imaging) will be used to measure changes in brain tumor size (cm^2). | one year | 
| Overall Survival | Participants were followed until reported death | one year | 
| Ketosis | Urine and blood ketosis (mmol/L) were measured | one year | 
| Quality of Life | quality of life measured by the Karnofsky Performance Scale | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketogenic diet, recurrent glioblastoma, chemotherapy