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

Overview

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).

Full Title of Study: “Ketogenic Diet Adjunctive to High Dose Methotrexate Chemotherapy for Primary Central Nervous System Lymphoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

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.

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • The chemosensitivity of tumor
    • Time Frame: Two years
    • The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)
  • Long term effect of chemotherapy
    • Time Frame: Two years
    • The average time from complete remission of tumor to relapse
  • overall survival
    • Time Frame: Three years
    • Participants will be followed until reported death to calculate overall survival
  • Quality of life
    • Time Frame: Two years
    • Short Form 36 Questionnaire will be used to assess patients’ quality of life

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Tiantan Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Song Lin, Professor – Beijing Tiantan Hospital
  • Overall Official(s)
    • Song Lin, M.D., Principal Investigator, Beijing Tiantan Hospital
  • Overall Contact(s)
    • Song Lin, M.D., 861067096509, linsong2005@126.com

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