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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02983942

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Primary Central Nervous System Lymphoma	Dietary Supplement: ketogenic diet Dietary Supplement: Routine diet	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ketogenic Diet Adjunctive to High Dose Methotrexate Chemotherapy for Primary Central Nervous System Lymphoma

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	Dietary Supplement: ketogenic diet Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.
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.	Dietary Supplement: Routine diet Routine diet is given without blood ketone requirement

Arm

Intervention/Treatment

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.

Dietary Supplement: ketogenic diet

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

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.

Dietary Supplement: Routine diet

Routine diet is given without blood ketone requirement

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-70
Histopathologically confirmed PCNSL
No systemic involvement
Ability and willingness to sign informed consent
Normal liver and kidney function
Karnofsky Performance Score of 60 or more

Exclusion Criteria:

Any systemic involvement of the tumor
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
Uncontrolled hyperlipidemia or hyperglycemia
Human immunodeficiency virus positive, or hepatitis C positive
Pregnancy of breastfeeding
Inability or unwillingness to give written informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital	Beijing	Beijing	China	100050

Sponsors and Collaborators

Beijing Tiantan Hospital

Investigators

Principal Investigator: Song Lin, M.D., Beijing Tiantan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Song Lin, Professor, Beijing Tiantan Hospital

ClinicalTrials.gov Identifier:

NCT02983942

Other Study ID Numbers:

B0010

First Posted:

Dec 6, 2016

Last Update Posted:

Dec 6, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Song Lin, Professor, Beijing Tiantan Hospital

ketogenic diet

Primary Central Nervous System Lymphoma

chemotherapy

Additional relevant MeSH terms:

Lymphoma

Study Results

No Results Posted as of Dec 6, 2016