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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.
Routine diet is given without blood ketone requirement
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
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
Time frame: Two years
The chemosensitivity of tumor
The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)
Time frame: Two years
Long term effect of chemotherapy
The average time from complete remission of tumor to relapse
Time frame: Two years
overall survival
Participants will be followed until reported death to calculate overall survival
Time frame: Three years
Quality of life
Short Form 36 Questionnaire will be used to assess patients' quality of life
Time frame: Two years
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