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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketogenic diet group | Experimental | 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. |
|
| routine diet group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketogenic diet | Dietary Supplement | Ketogenic diet is given to maintain blood ketone level above 2 mmol/L. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Lin, M.D. | Contact | 861067096509 | linsong2005@126.com | |
| Chun Zeng, M.D. | Contact | 861067096509 | zengchun79@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Song Lin, M.D. | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Routine diet | Dietary Supplement | Routine diet is given without blood ketone requirement |
|
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 |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |