<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/NCT01716468</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00000367</org_study_id>
    <nct_id>NCT01716468</nct_id>
  </id_info>
  <brief_title>Ketogenic Diet in Advanced Cancer</brief_title>
  <official_title>A Low-Carbohydrate Diet for Advanced or Metastatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Pittsburgh Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Pittsburgh Healthcare System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and tolerability of a modified low&#xD;
      carbohydrate diet, determine if quality of life is improved and to determine if the diet has&#xD;
      any effect on tumor growth (size or spread) and or to determine if there is any effect on&#xD;
      progression free survival (PFS) and overall survival (OS) of subjects enrolled in the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In their natural state within the body, cells normally depend on cellular respiration as the&#xD;
      source of energy and ATP. During times of complete or partial food deprivation these cells&#xD;
      can also rely on ketosis as an additional energy source. Tumor cells in contrast are&#xD;
      defective in this respect, lacking in the ability to utilize ketone bodies for energy and&#xD;
      instead are heavily dependent on glycolysis for their survival. Malignant cells depend&#xD;
      heavily on glycolysis for energy production even in high oxygen states. If the investigators&#xD;
      limit the supply of glucose, glycolysis would decrease and tumor cells would lose their main&#xD;
      source of energy supply.&#xD;
&#xD;
      In addition, increased carbohydrate intake is sensed by the pancreas and results in increased&#xD;
      insulin secretion. Insulin is important for normal growth in the body and is a potent growth&#xD;
      factor stimulating mitosis via signal transduction and DNA synthesis. It is a potent growth&#xD;
      factor which acts by binding to cell membrane insulin receptors and stimulates mitosis via&#xD;
      protein kinase B/Akt- mediated signal transduction and DNA synthesis.&#xD;
&#xD;
      Insulin also has anti-apoptotic properties, meaning less tumor cell death. Increased&#xD;
      circulating insulin levels have been associated with increasing risk of certain cancers (i.e.&#xD;
      prostate and colon cancer), but no association with serum glucose levels (8). By limiting&#xD;
      carbohydrate intake, the investigators might expect decreased tumor growth and increased&#xD;
      tumor cell destruction.&#xD;
&#xD;
      Most human and mouse tumors take up more glucose than their surrounding normal tissue. By&#xD;
      using positron emission tomography with fluoro-deoxy-glucose, FDG-PET scans can be used to&#xD;
      detect and monitor tumor response to chemotherapy and radiation.&#xD;
&#xD;
      In this study, PET/CT scanning would be utilized to measure the amount of (at the screening&#xD;
      visit) glucose activity within certain tumors, before and after the diet.&#xD;
&#xD;
      Primary Aim: To determine the safety and tolerability of a modified low carbohydrate diet in&#xD;
      people with advanced cancer across different tumor types.&#xD;
&#xD;
      Hypothesi(e)s: The long term tolerability of the KD (Ketogenic Diet) has been established&#xD;
      (Groesbeck et al., 2006). Recent studies involving human patients with brain cancer showed&#xD;
      tolerability of the Ketogenic diet over a period as long as 19 months with minimal side&#xD;
      effects. However the MAD (Modified Atkins Diet) long term side effects are as of yet unclear.&#xD;
      Given the similarity of the MAD compared to the KD, and being less restrictive, the long term&#xD;
      side effects (kidney stones, dyslipidemia, gastroesophageal reflux) of the MAD is projected&#xD;
      to be similar, if not reduced, in comparison to the KD. Modified carbohydrate diets as well&#xD;
      as ketogenic diets have been tolerated by people with epilepsy. It is hypothesized that the&#xD;
      effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels&#xD;
      will be minimal and tolerable even by cancer patients over a prolonged period of time, up to&#xD;
      12 months or possibly longer. Given the tolerability of the diet in brain cancer patients, it&#xD;
      is hypothesized that patients with other types of tumors will find this diet tolerable and&#xD;
      safe.&#xD;
&#xD;
      Secondary Aims: To determine if quality of life is improved with the use of this diet. To&#xD;
      determine if the diet has any effect on tumor growth (size or spread) or to determine if&#xD;
      there is any effect on progression free survival (PFS) and overall survival (OS) of subjects&#xD;
      enrolled in the study.&#xD;
&#xD;
      Hypothesis(e): The diet showed good tolerance in human adult patient studies wherein the diet&#xD;
      was tolerated well up to 12 weeks in a group of diverse tumor types and up to more than 10&#xD;
      years in a glioma patient. It is hypothesized that cancer patients will be able to tolerate&#xD;
      this diet at 16 weeks or more. Studies in animals as well as in tumor tissue models show&#xD;
      slowing of tumor growth, and in some instances also showed tumor shrinkage. Human case&#xD;
      reports and a small study of 16 patients show tumor shrinkage and stable disease while on the&#xD;
      diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.</measure>
    <time_frame>16 weeks</time_frame>
    <description>Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Advanced or metastatic cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).All participants will be assigned to a ketogenic diet. There are no randomization to other separate arms since this is a safety and feasibility study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ketogenic Diet</intervention_name>
    <description>modified ketogenic diet</description>
    <arm_group_label>Advanced or metastatic cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Subjects must meet all of the following criteria to be eligible for the study:&#xD;
&#xD;
          -  18 years of age or older.&#xD;
&#xD;
          -  English speaking and written informed consent obtained.&#xD;
&#xD;
          -  Patients presenting to the VAPHS Oncology inpatient or outpatient clinic with cancer&#xD;
             of advanced or metastatic stage.&#xD;
&#xD;
          -  Must have measurable disease at least 1 cm in greatest diameter on CT or MRI scanning.&#xD;
             If a new FDG avid satellite lesions are noted this will be counted as disease&#xD;
             progression. The minimum size is 1 cm. The tumor will be measured at the longest&#xD;
             diameter. Either the primary tumor or metastatic tumor, either may be used. In absence&#xD;
             of primary tumor, we usually measure the next largest metastatic lesion. The tumor&#xD;
             will be chose by using RECIST criteria measure (at the screening visit) tumors, then&#xD;
             using the 4 response criteria, CR complete response= disappearance of all target&#xD;
             lesions, PR= 30% decrease in the sum of the longest diameter of target lesions, PD&#xD;
             progressive disease= 20% increase in the sum of the longest diameter of target&#xD;
             lesions, and SD stable disease= small changes that don't meet the above criteria&#xD;
&#xD;
          -  Patients must have solid, advanced or metastatic tumors, and have failed to respond to&#xD;
             chemotherapy or on chemotherapy holiday.&#xD;
&#xD;
          -  Tumors must be PET positive in primary or metastatic site.&#xD;
&#xD;
          -  Patients must not be actively receiving chemotherapy after holiday or have refused or&#xD;
             failed one or more prior chemotherapy or radiotherapy treatment.&#xD;
&#xD;
          -  Subjects may be enrolled in any other studies as long as they are not under an active&#xD;
             form of chemotherapy or radiotherapy intervention.&#xD;
&#xD;
          -  No subjects will be excluded based on their race, religion, ethnicity, and gender or&#xD;
             HIV status, as applicable.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Prisoners or subjects who are involuntarily incarcerated.&#xD;
&#xD;
          -  Secondary brain metastases.&#xD;
&#xD;
          -  History of Gout.&#xD;
&#xD;
          -  AST or ATL &gt; 1.5 X ULN.&#xD;
&#xD;
          -  Creatinine &gt; 2.0.&#xD;
&#xD;
          -  Hematologic malignancies&#xD;
&#xD;
          -  BMI &lt; 22.&#xD;
&#xD;
          -  History of kidney disease or kidney stones.&#xD;
&#xD;
          -  Receiving chemotherapy including biologics.&#xD;
&#xD;
          -  Recent AMI/TIA or stroke within one month of study entry.&#xD;
&#xD;
          -  ECOG performance status of 3 or worse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jocelyn Tan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Pittsburgh Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Pittsburgh Healthcare System</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>February 9, 2016</results_first_submitted>
  <results_first_submitted_qc>April 9, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 9, 2016</results_first_posted>
  <last_update_submitted>April 9, 2016</last_update_submitted>
  <last_update_submitted_qc>April 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Pittsburgh Healthcare System</investigator_affiliation>
    <investigator_full_name>Jocelyn Tan</investigator_full_name>
    <investigator_title>Attending Physician-Hematology/Oncology</investigator_title>
  </responsible_party>
  <keyword>Ketogenic Diet, Advanced Cancer, Neoplasm</keyword>
  <keyword>Low carbohydrate</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Advanced or Metastatic Cancer</title>
          <description>Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Advanced or Metastatic Cancer</title>
          <description>Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65" lower_limit="44" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.</title>
        <description>Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.</description>
        <time_frame>16 weeks</time_frame>
        <population>Solid cancers or blood cancers with measurable components in advanced or metastatic stages.</population>
        <group_list>
          <group group_id="O1">
            <title>Advanced or Metastatic Cancer</title>
            <description>Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).</description>
          </group>
        </group_list>
        <measure>
          <title>To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.</title>
          <description>Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.</description>
          <population>Solid cancers or blood cancers with measurable components in advanced or metastatic stages.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Advanced or Metastatic Cancer</title>
          <description>Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Grade 1 Weight Loss</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Grade 2 weight Loss</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jocelyn Tan, MD</name_or_title>
      <organization>VA Pittsburgh Healthcare System</organization>
      <phone>412-360-6178</phone>
      <email>Jocelyn.Tan@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01716468
org study id: PRO00000367
nct id: NCT01716468
lead sponsor: 
has dmc: No
The purpose of this study is to determine the safety and tolerability of a modified low
      carbohydrate diet, determine if quality of life is improved and to determine if the diet has
      any effect on tumor growth (size or spread) and or to determine if there is any effect on
      progression free survival (PFS) and overall survival (OS) of subjects enrolled in the study.
In their natural state within the body, cells normally depend on cellular respiration as the
      source of energy and ATP. During times of complete or partial food deprivation these cells
      can also rely on ketosis as an additional energy source. Tumor cells in contrast are
      defective in this respect, lacking in the ability to utilize ketone bodies for energy and
      instead are heavily dependent on glycolysis for their survival. Malignant cells depend
      heavily on glycolysis for energy production even in high oxygen states. If the investigators
      limit the supply of glucose, glycolysis would decrease and tumor cells would lose their main
      source of energy supply.

      In addition, increased carbohydrate intake is sensed by the pancreas and results in increased
      insulin secretion. Insulin is important for normal growth in the body and is a potent growth
      factor stimulating mitosis via signal transduction and DNA synthesis. It is a potent growth
      factor which acts by binding to cell membrane insulin receptors and stimulates mitosis via
      protein kinase B/Akt- mediated signal transduction and DNA synthesis.

      Insulin also has anti-apoptotic properties, meaning less tumor cell death. Increased
      circulating insulin levels have been associated with increasing risk of certain cancers (i.e.
      prostate and colon cancer), but no association with serum glucose levels (8). By limiting
      carbohydrate intake, the investigators might expect decreased tumor growth and increased
      tumor cell destruction.

      Most human and mouse tumors take up more glucose than their surrounding normal tissue. By
      using positron emission tomography with fluoro-deoxy-glucose, FDG-PET scans can be used to
      detect and monitor tumor response to chemotherapy and radiation.

      In this study, PET/CT scanning would be utilized to measure the amount of (at the screening
      visit) glucose activity within certain tumors, before and after the diet.

      Primary Aim: To determine the safety and tolerability of a modified low carbohydrate diet in
      people with advanced cancer across different tumor types.

      Hypothesi(e)s: The long term tolerability of the KD (Ketogenic Diet) has been established
      (Groesbeck et al., 2006). Recent studies involving human patients with brain cancer showed
      tolerability of the Ketogenic diet over a period as long as 19 months with minimal side
      effects. However the MAD (Modified Atkins Diet) long term side effects are as of yet unclear.
      Given the similarity of the MAD compared to the KD, and being less restrictive, the long term
      side effects (kidney stones, dyslipidemia, gastroesophageal reflux) of the MAD is projected
      to be similar, if not reduced, in comparison to the KD. Modified carbohydrate diets as well
      as ketogenic diets have been tolerated by people with epilepsy. It is hypothesized that the
      effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels
      will be minimal and tolerable even by cancer patients over a prolonged period of time, up to
      12 months or possibly longer. Given the tolerability of the diet in brain cancer patients, it
      is hypothesized that patients with other types of tumors will find this diet tolerable and
      safe.

      Secondary Aims: To determine if quality of life is improved with the use of this diet. To
      determine if the diet has any effect on tumor growth (size or spread) or to determine if
      there is any effect on progression free survival (PFS) and overall survival (OS) of subjects
      enrolled in the study.

      Hypothesis(e): The diet showed good tolerance in human adult patient studies wherein the diet
      was tolerated well up to 12 weeks in a group of diverse tumor types and up to more than 10
      years in a glioma patient. It is hypothesized that cancer patients will be able to tolerate
      this diet at 16 weeks or more. Studies in animals as well as in tumor tissue models show
      slowing of tumor growth, and in some instances also showed tumor shrinkage. Human case
      reports and a small study of 16 patients show tumor shrinkage and stable disease while on the
      diet.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.
time frame: 16 weeks
description: Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.
arm group label: Advanced or metastatic cancer
arm group type: Other
description: Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).All participants will be assigned to a ketogenic diet. There are no randomization to other separate arms since this is a safety and feasibility study.
intervention type: Other
intervention name: Ketogenic Diet
description: modified ketogenic diet
arm group label: Advanced or metastatic cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jocelyn Tan, MD
role: Principal Investigator
affiliation: VA Pittsburgh Healthcare System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA Pittsburgh Healthcare System
investigator full name: Jocelyn Tan
investigator title: Attending Physician-Hematology/Oncology
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certain agreements: 
point of contact: 