<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/NCT03010657</url>
  </required_header>
  <id_info>
    <org_study_id>HREBA-CC-16-0851</org_study_id>
    <nct_id>NCT03010657</nct_id>
  </id_info>
  <brief_title>Eating Strategies for Chemotherapy Treatment</brief_title>
  <official_title>Eating Strategies for Chemotherapy Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates an eating strategy in adults undergoing chemotherapy for non-small cell&#xD;
      lung cancer. Subjects will be allocated to a randomized or observational arm based on&#xD;
      baseline measurements. In the randomized arm, half of participants will add certain foods to&#xD;
      what they normally eat, while the other half will continue to eat their habitual diet.&#xD;
      Subjects in the observational arm will continue to eat their habitual diet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 27, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in computed tomography-derived muscle mass</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>CT scan from the third vertebrae region</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in strength</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>hand grip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in physical performance</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>short physical performance battery protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tumor response to therapy</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>change in computed tomography-derived tumor size</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment-induced toxicity</measure>
    <time_frame>6 weeks</time_frame>
    <description>National Cancer Institute Common Toxicity Criteria for toxicity grading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in quality of life</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in nutritional status</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>Patient Generated Subjective Global Assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in inflammatory status</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>C-reactive protein/albumin ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in vitamin D status</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>plasma 25-hydroxyvitamin D total, D2, and D3</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <condition>Antineoplastic Agents</condition>
  <arm_group>
    <arm_group_label>Experimental intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will add certain foods to what they normally eat.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-experimental intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will continue eating normally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will continue eating normally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental intervention</intervention_name>
    <description>Subjects will be asked to consume certain foods during chemotherapy treatment.</description>
    <arm_group_label>Experimental intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a newly confirmed diagnosis of non-small cell lung cancer scheduled for&#xD;
             first line chemotherapy&#xD;
&#xD;
          -  Patients with a computed tomography (CT) image, which includes scans of the 3rd lumbar&#xD;
             region, taken within 45 days before initiation of chemotherapy&#xD;
&#xD;
          -  Ability to maintain oral intake&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 / Karnofsky&#xD;
             Performance Status between 60-100&#xD;
&#xD;
          -  Ability to give written, informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-morbidities that would be expected to interfere with the primary outcome measure&#xD;
&#xD;
          -  Patients on long term drugs or supplements that modify muscle metabolism&#xD;
&#xD;
          -  Life expectancy &lt;3 months&#xD;
&#xD;
          -  Severe food restriction(s) that would inhibit the study intervention food modification&#xD;
&#xD;
          -  An inability to comply with study instructions&#xD;
&#xD;
          -  Patients engaged in a total of ≥50 minutes of moderate-to-vigorous cardiovascular&#xD;
             exercise per week and/or structured resistance exercise occurring ≥2 times per week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vera Mazurak, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <!-- 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/NCT03010657
org study id: HREBA-CC-16-0851
nct id: NCT03010657
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates an eating strategy in adults undergoing chemotherapy for non-small cell
      lung cancer. Subjects will be allocated to a randomized or observational arm based on
      baseline measurements. In the randomized arm, half of participants will add certain foods to
      what they normally eat, while the other half will continue to eat their habitual diet.
      Subjects in the observational arm will continue to eat their habitual diet.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: change in computed tomography-derived muscle mass
time frame: Baseline and 10 weeks
description: CT scan from the third vertebrae region
measure: change in strength
time frame: Baseline and 10 weeks
description: hand grip
measure: change in physical performance
time frame: Baseline and 10 weeks
description: short physical performance battery protocol
measure: tumor response to therapy
time frame: Baseline and 10 weeks
description: change in computed tomography-derived tumor size
measure: treatment-induced toxicity
time frame: 6 weeks
description: National Cancer Institute Common Toxicity Criteria for toxicity grading
measure: change in quality of life
time frame: Baseline and 10 weeks
description: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)
measure: change in nutritional status
time frame: Baseline and 10 weeks
description: Patient Generated Subjective Global Assessment
measure: change in inflammatory status
time frame: Baseline and 10 weeks
description: C-reactive protein/albumin ratio
measure: change in vitamin D status
time frame: Baseline and 10 weeks
description: plasma 25-hydroxyvitamin D total, D2, and D3
arm group label: Experimental intervention
arm group type: Experimental
description: Subjects will add certain foods to what they normally eat.
arm group label: Non-experimental intervention
arm group type: No Intervention
description: Subjects will continue eating normally.
arm group label: Observational
arm group type: No Intervention
description: Subjects will continue eating normally.
intervention type: Other
intervention name: Experimental intervention
description: Subjects will be asked to consume certain foods during chemotherapy treatment.
arm group label: Experimental intervention
criteria: 
gender: All
minimum age: 19 Years
maximum age: 100 Years
healthy volunteers: No
last name: Vera Mazurak, Ph.D.
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung