<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02983942</url>
  </required_header>
  <id_info>
    <org_study_id>B0010</org_study_id>
    <nct_id>NCT02983942</nct_id>
  </id_info>
  <brief_title>Ketogenic Diet Adjunctive to HD-MTX Chemotherapy for Primary Central Nervous System Lymphoma</brief_title>
  <official_title>Ketogenic Diet Adjunctive to High Dose Methotrexate Chemotherapy for Primary Central Nervous System Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tiantan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ketogenic diet has shown auxiliary effect on treatment of malignant tumors require high&#xD;
      glucose consumption. This study is designed to evaluate the safety and efficacy of ketogenic&#xD;
      diet adjunctive to high dose methotrexate(HD-MTX) chemotherapy for primary central nervous&#xD;
      system lymphoma (PCNSL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a pilot study of primary central nervous system(CNS) lymphoma patients, ketogenic diet was&#xD;
      given in adjunction with standard HD-MTX chemotherapy as interventional group; standard&#xD;
      HD-MTX is given with routine diet as control group. The primary endpoint is the safety of&#xD;
      ketogenic diet in PCNSL patients receiving chemotherapy, secondary endpoints include rate of&#xD;
      complete remission, remission time, rate of tumor relapse and overall survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>Two years</time_frame>
    <description>The number and incidence (%) of treatment related adverse events among participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The chemosensitivity of tumor</measure>
    <time_frame>Two years</time_frame>
    <description>The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term effect of chemotherapy</measure>
    <time_frame>Two years</time_frame>
    <description>The average time from complete remission of tumor to relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>Three years</time_frame>
    <description>Participants will be followed until reported death to calculate overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Two years</time_frame>
    <description>Short Form 36 Questionnaire will be used to assess patients' quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Primary Central Nervous System Lymphoma</condition>
  <arm_group>
    <arm_group_label>ketogenic diet group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>routine diet group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ketogenic diet</intervention_name>
    <description>Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.</description>
    <arm_group_label>ketogenic diet group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Routine diet</intervention_name>
    <description>Routine diet is given without blood ketone requirement</description>
    <arm_group_label>routine diet group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-70&#xD;
&#xD;
          2. Histopathologically confirmed PCNSL&#xD;
&#xD;
          3. No systemic involvement&#xD;
&#xD;
          4. Ability and willingness to sign informed consent&#xD;
&#xD;
          5. Normal liver and kidney function&#xD;
&#xD;
          6. Karnofsky Performance Score of 60 or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any systemic involvement of the tumor&#xD;
&#xD;
          2. Systemic illness or medical condition may pose additional risk, including cardiac,&#xD;
             metabolic or endocrine disorders; incompensated renal or liver disfunction; history of&#xD;
             renal calculi, hyperuricemia, hyper calcemia, mitochondrial disease, known disorder of&#xD;
             fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis&#xD;
&#xD;
          3. Uncontrolled hyperlipidemia or hyperglycemia&#xD;
&#xD;
          4. Human immunodeficiency virus positive, or hepatitis C positive&#xD;
&#xD;
          5. Pregnancy of breastfeeding&#xD;
&#xD;
          6. Inability or unwillingness to give written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Song Lin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tiantan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Song Lin, M.D.</last_name>
    <phone>861067096509</phone>
    <email>linsong2005@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chun Zeng, M.D.</last_name>
    <phone>861067096509</phone>
    <email>zengchun79@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Song Lin, M.D.</last_name>
      <phone>861067096509</phone>
      <email>linsong2005@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Chun Zeng, M.D.</last_name>
      <phone>861067096509</phone>
      <email>zengchun79@aliyun.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Song Lin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>ketogenic diet</keyword>
  <keyword>Primary Central Nervous System Lymphoma</keyword>
  <keyword>chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02983942
org study id: B0010
nct id: NCT02983942
lead sponsor: 
has dmc: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with treatment related adverse events as assessed by CTCAE v4.0
time frame: Two years
description: The number and incidence (%) of treatment related adverse events among participants
measure: The chemosensitivity of tumor
time frame: Two years
description: The rate of complete remission after treatment assessed according to serial contrast Magnetic Resonance Imaging (MRI)
measure: Long term effect of chemotherapy
time frame: Two years
description: The average time from complete remission of tumor to relapse
measure: overall survival
time frame: Three years
description: Participants will be followed until reported death to calculate overall survival
measure: Quality of life
time frame: Two years
description: Short Form 36 Questionnaire will be used to assess patients' quality of life
arm group label: ketogenic diet group
arm group type: Experimental
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 group label: routine diet group
arm group type: Active Comparator
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: ketogenic diet
description: Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.
arm group label: ketogenic diet group
intervention type: Dietary Supplement
intervention name: Routine diet
description: Routine diet is given without blood ketone requirement
arm group label: routine diet group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Song Lin, M.D.
role: Principal Investigator
affiliation: Beijing Tiantan Hospital
last name: Song Lin, M.D.
phone: 861067096509
email: linsong2005@126.com
last name: Chun Zeng, M.D.
phone: 861067096509
email: zengchun79@aliyun.com
facility: 
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Song Lin
investigator title: Professor
mesh term: Lymphoma
sharing ipd: Undecided