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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.

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.

Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.

ketogenic diet

Routine diet is given without blood ketone requirement

Routine diet

Song Lin, M.D.

Chun Zeng, M.D.

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).

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.

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

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

The number and incidence (%) of treatment related adverse events among participants

The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)

The average time from complete remission of tumor to relapse

Participants will be followed until reported death to calculate overall survival

Short Form 36 Questionnaire will be used to assess patients' quality of life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma	NCT02983942	Primary Central...	ketogenic diet Routine diet	18 Years - 70 Years	Beijing Tiantan Hospital
Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma	NCT02983942	Primary Central...	ketogenic diet Routine diet	18 Years - 70 Years	Beijing Tiantan Hospital

Spots Global Cancer Trial Database for routine diet

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