Back to resultsKetogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma
Primary Purpose
Primary Central Nervous System Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ketogenic diet
Routine diet
Sponsored by
About this trial
This is an interventional treatment trial for Primary Central Nervous System Lymphoma focused on measuring ketogenic diet, Primary Central Nervous System Lymphoma, chemotherapy
Eligibility Criteria
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.
Sites / Locations
- Beijing Tiantan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ketogenic diet group
routine diet group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The chemosensitivity of tumor
The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)
Long term effect of chemotherapy
The average time from complete remission of tumor to relapse
overall survival
Participants will be followed until reported death to calculate overall survival
Quality of life
Short Form 36 Questionnaire will be used to assess patients' quality of life
Full Information
NCT ID
NCT02983942
First Posted
November 29, 2016
Last Updated
December 2, 2016
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02983942
Brief Title
Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma
Official Title
Ketogenic Diet Adjunctive to High Dose Methotrexate Chemotherapy for Primary Central Nervous System Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Central Nervous System Lymphoma
Keywords
ketogenic diet, Primary Central Nervous System Lymphoma, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ketogenic diet group
Arm Type
Experimental
Arm Description
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.
Arm Title
routine diet group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
ketogenic diet
Intervention Description
Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.
Intervention Type
Dietary Supplement
Intervention Name(s)
Routine diet
Intervention Description
Routine diet is given without blood ketone requirement
Primary Outcome Measure Information:
Title
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Description
The number and incidence (%) of treatment related adverse events among participants
Time Frame
Two years
Secondary Outcome Measure Information:
Title
The chemosensitivity of tumor
Description
The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)
Time Frame
Two years
Title
Long term effect of chemotherapy
Description
The average time from complete remission of tumor to relapse
Time Frame
Two years
Title
overall survival
Description
Participants will be followed until reported death to calculate overall survival
Time Frame
Three years
Title
Quality of life
Description
Short Form 36 Questionnaire will be used to assess patients' quality of life
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Song Lin, M.D.
Phone
861067096509
Email
linsong2005@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Zeng, M.D.
Phone
861067096509
Email
zengchun79@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Song Lin, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Lin, M.D.
Phone
861067096509
Email
linsong2005@126.com
First Name & Middle Initial & Last Name & Degree
Chun Zeng, M.D.
Phone
861067096509
Email
zengchun79@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma
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