Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma

Study Overview
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Brief Summary
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Ketogenic diet has shown auxiliary effect on treatment of malignant tumors require high glucose consumption. This study is designed to evaluate the safety and efficacy of ketogenic diet adjunctive to high dose methotrexate(HD-MTX) chemotherapy for primary central nervous system lymphoma (PCNSL).

Detailed Description
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In a pilot study of primary central nervous system(CNS) lymphoma patients, ketogenic diet was given in adjunction with standard HD-MTX chemotherapy as interventional group; standard HD-MTX is given with routine diet as control group. The primary endpoint is the safety of ketogenic diet in PCNSL patients receiving chemotherapy, secondary endpoints include rate of complete remission, remission time, rate of tumor relapse and overall survival.

Official Title
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Ketogenic Diet Adjunctive to High Dose Methotrexate Chemotherapy for Primary Central Nervous System Lymphoma

Conditions
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Primary Central Nervous System Lymphoma

Intervention / Treatment
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* Dietary Supplement: ketogenic diet
* Dietary Supplement: Routine diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 Histopathologically confirmed PCNSL No systemic involvement Ability and willingness to sign informed consent Normal liver and kidney function Karnofsky Performance Score of 60 or more Exclusion Criteria: Any systemic involvement of the tumor Systemic illness or medical condition may pose additional risk, including cardiac, metabolic or endocrine disorders; incompensated renal or liver disfunction; history of renal calculi, hyperuricemia, hyper calcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis Uncontrolled hyperlipidemia or hyperglycemia Human immunodeficiency virus positive, or hepatitis C positive Pregnancy of breastfeeding Inability or unwillingness to give written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketogenic diet group<br>Ketogenic diet is given in combination to standard HD-MTX chemotherapy to primary central nervous system lymphoma patients. Blood ketone is kept no less than 2mmol/L during the initial 4 cycles of chemotherapy. The adverse events is monitored and recorded. Tumor response is evaluated and recorded. | Dietary Supplement: ketogenic diet<br>* Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.<br>|
| Active Comparator: routine diet group<br>Standard HD-MTX chemotherapy is given with routine diet.Blood ketone is measured and recorded. The adverse events is monitored and recorded. Tumor response is evaluated and recorded. | Dietary Supplement: Routine diet<br>* Routine diet is given without blood ketone requirement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment related adverse events as assessed by CTCAE v4.0 | The number and incidence (%) of treatment related adverse events among participants | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The chemosensitivity of tumor | The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI) | Two years | 
| Long term effect of chemotherapy | The average time from complete remission of tumor to relapse | Two years | 
| overall survival | Participants will be followed until reported death to calculate overall survival | Three years | 
| Quality of life | Short Form 36 Questionnaire will be used to assess patients' quality of life | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketogenic diet, Primary Central Nervous System Lymphoma, chemotherapy