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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02983942
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Song Lin, M.D.
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Central Nervous System Lymphoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: ketogenic diet group

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.

Active Comparator: routine diet group

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.

Interventions

Dietary Supplement: - ketogenic diet

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

Dietary Supplement: - Routine diet

Routine diet is given without blood ketone requirement

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Tiantan Hospital, Beijing, Beijing, China

Status

Not yet recruiting

Address

Beijing Tiantan Hospital

Beijing, Beijing, 100050

Site Contact

Song Lin, M.D.

[email protected]

861067096509

Clinical Trial Finder