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

NCT ID: NCT02983942

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Primary Central Nervous System Lymphoma

Keywords

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ketogenic diet Primary Central Nervous System Lymphoma chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type ACTIVE_COMPARATOR

Routine diet

Intervention Type DIETARY_SUPPLEMENT

Routine diet is given without blood ketone requirement

Interventions

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ketogenic diet

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

Intervention Type DIETARY_SUPPLEMENT

Routine diet

Routine diet is given without blood ketone requirement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Song Lin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Song Lin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Song Lin, M.D.

Role: CONTACT

Phone: 861067096509

Email: [email protected]

Chun Zeng, M.D.

Role: CONTACT

Phone: 861067096509

Email: [email protected]

Facility Contacts

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Song Lin, M.D.

Role: primary

Chun Zeng, M.D.

Role: backup

Other Identifiers

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B0010

Identifier Type: -

Identifier Source: org_study_id