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

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ClinicalTrials.gov Identifier: NCT02983942
Recruitment Status : Not yet recruiting
First Posted : December 6, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Song Lin, Beijing Tiantan Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




Primary Outcome Measures :
  1. Number of participants with treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: Two years ]
    The number and incidence (%) of treatment related adverse events among participants


Secondary Outcome Measures :
  1. The chemosensitivity of tumor [ Time Frame: Two years ]
    The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)

  2. Long term effect of chemotherapy [ Time Frame: Two years ]
    The average time from complete remission of tumor to relapse

  3. overall survival [ Time Frame: Three years ]
    Participants will be followed until reported death to calculate overall survival

  4. Quality of life [ Time Frame: Two years ]
    Short Form 36 Questionnaire will be used to assess patients' quality of life



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983942


Contacts
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Contact: Song Lin, M.D. 861067096509 linsong2005@126.com
Contact: Chun Zeng, M.D. 861067096509 zengchun79@aliyun.com

Locations
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China, Beijing
Beijing Tiantan Hospital Not yet recruiting
Beijing, Beijing, China, 100050
Contact: Song Lin, M.D.    861067096509    linsong2005@126.com   
Contact: Chun Zeng, M.D.    861067096509    zengchun79@aliyun.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Song Lin, M.D. Beijing Tiantan Hospital

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Responsible Party: Song Lin, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02983942     History of Changes
Other Study ID Numbers: B0010
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Song Lin, Beijing Tiantan Hospital:
ketogenic diet
Primary Central Nervous System Lymphoma
chemotherapy
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases