Primary Central Nervous System Lymphoma
Conditions
Keywords
ketogenic diet, Primary Central Nervous System Lymphoma, chemotherapy
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTketogenic diet
Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.
DIETARY_SUPPLEMENTRoutine diet
Routine diet is given without blood ketone requirement
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 2. Histopathologically confirmed PCNSL 3. No systemic involvement 4. Ability and willingness to sign informed consent 5. Normal liver and kidney function 6. Karnofsky Performance Score of 60 or more
Exclusion criteria
1. Any systemic involvement of the tumor 2. 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 3. Uncontrolled hyperlipidemia or hyperglycemia 4. Human immunodeficiency virus positive, or hepatitis C positive 5. Pregnancy of breastfeeding 6. Inability or unwillingness to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment related adverse events as assessed by CTCAE v4.0 | Two years | The number and incidence (%) of treatment related adverse events among participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The chemosensitivity of tumor | Two years | The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI) |
| Long term effect of chemotherapy | Two years | The average time from complete remission of tumor to relapse |
| overall survival | Three years | Participants will be followed until reported death to calculate overall survival |
| Quality of life | Two years | Short Form 36 Questionnaire will be used to assess patients' quality of life |
Countries
China
Contacts
Primary ContactSong Lin, M.D.
Backup ContactChun Zeng, M.D.
Outcome results
None listed