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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Beijing Tiantan Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Beijing Tiantan Hospital

Dates:
Date Received: November 29, 2016
Date Started: January 2017
Date Completion: December 2019
Last Updated: December 2, 2016
Last Verified: December 2016