<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/NCT04476082</url>
  </required_header>
  <id_info>
    <org_study_id>BB 071/20</org_study_id>
    <nct_id>NCT04476082</nct_id>
  </id_info>
  <brief_title>Nutrition in Gastrointestinal Tumors</brief_title>
  <acronym>NutriGIT</acronym>
  <official_title>Analysis of Nutritional Status in Patients With Malignant Tumor Diseases of the Gastrointestinal Tract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</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>
      Malnutrition and loss of muscle mass frequently occur in patients undergoing chemotherapy and&#xD;
      can negatively effect therapy outcome. Especially patients with cancer of the&#xD;
      gastrointestinal tract are often affected by malnutrition. Therefore, this study aims to&#xD;
      examine changes in nutritional status of patients with cancer of the gastrointestinal tract&#xD;
      during chemotherapy. Findings of this study will help to improve nutritional treatment of&#xD;
      patients undergoing chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malnutrition and sarcopenia are common complications in patients with malignant diseases of&#xD;
      the gastrointestinal tract. During chemotherapy there is a high risk of further impairment of&#xD;
      nutritional status due to anorexia, nausea, emesis and other gastrointestinal conditions that&#xD;
      adversely impact food assimilation or absorption. Findings on changes of nutritional status&#xD;
      during chemotherapy are scarce but of paramount importance for adequate nutrition therapy.&#xD;
      Therefore, this study aims to provide a detailed description of changes in nutritional status&#xD;
      of patients with a malignant condition of the gastrointestinal tract during chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">December 6, 2022</completion_date>
  <primary_completion_date type="Actual">December 6, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria)</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Change in prevalence of malnutrition according to the GLIM criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of Malnutrition According to the European Society for Clinical Nutrition and Metabolism criteria (ESPEN criteria)</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Change in prevalence of malnutrition according to the ESPEN criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal Muscle Mass</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in the skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Free Mass</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in the fat free mass measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Mass</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in the fat mass measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Body Water</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in the total Body water measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extracellular Water</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in the total extracellular water measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase Angle</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in the phase angle measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Weight</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in body weight measured in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in height measured in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in body mass index in kg/m^2 (calculated from the values obtained for body weight and height)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in waist circumference measured in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip Circumference</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in hip circumference measured in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-to-Hip Ratio</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper Arm Circumference</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in upper arm circumference measured in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triceps Skinfold Thickness</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in triceps skinfold thickness measured in millimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in muscle strength measured by a handgrip strength dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Function</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in muscle function measured by a 4-m gait speed test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sarcopenia According to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria)</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Change in prevalence of sarcopenia according to the EWGSOP2 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy Intake</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in energy intake assessed by 3-day weighed dietary record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein Intake</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in protein intake (in g/day) assessed by 3-day weighed dietary record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbohydrate Intake</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in carbohydrate intake (in g/day) assessed by 3-day weighed dietary record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Intake</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in fat intake (in g/day) assessed by 3-day weighed dietary record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Fiber Intake</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in dietary fiber intake (in g/day) assessed by 3-day weighed dietary record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in metabolic equivalent of task per day and activity level are assessed by employment of the German version of the International Physical Activity Questionnaire (IPAQ) Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Blood Count</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in complete blood count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma concentration of albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate Transaminase</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma concentration of aspartate transferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine Aminotransferase</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma concentration of alanine aminotransferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gamma-glutamyl Transferase</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma concentration of gamma-glutamyl transferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubin</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma concentration of bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma concentration of creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urea</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma concentration of urea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive Protein</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma concentration of C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Metabolome</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma metabolome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Transcriptome</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in plasma transcriptome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal Microbiome</measure>
    <time_frame>3 months after study enrollment</time_frame>
    <description>Changes in intestinal microbiome</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Oesophageal Cancer</condition>
  <condition>Colon Cancer</condition>
  <condition>Liver Cancer</condition>
  <condition>Rectal Cancer</condition>
  <condition>Bile Duct Cancer</condition>
  <condition>GIST, Malignant</condition>
  <condition>Neuroendocrine Tumors</condition>
  <condition>Small Intestine Cancer</condition>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Initial Diagnosis</arm_group_label>
    <description>Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ongoing Cytostatic Treatment</arm_group_label>
    <description>Patients with a malignant condition of the gastrointestinal tract already receiving cytostatic treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention - observational study only</intervention_name>
    <description>No intervention - observational study only</description>
    <arm_group_label>Initial Diagnosis</arm_group_label>
    <arm_group_label>Ongoing Cytostatic Treatment</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Plasma, Faeces&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited at University Medicine Greifswald (Northeast Germany). Patients&#xD;
        with initial diagnosis of a malignant condition of the gastrointestinal tract planned to&#xD;
        receive cytostatic treatment will be identified in the gastrointestinal ward of the&#xD;
        hosptial. Recruitment of patients receiving cytostatic treatment of a known malignant&#xD;
        condition of the gastrointestinal tract will take place in the hospital's cancer day unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with initial diagnosis of a malignant condition of the gastrointestinal tract&#xD;
             planned to receive cytostatic treatment.&#xD;
&#xD;
          -  ongoing cytostatic treatment of a known malignant condition of the gastrointestinal&#xD;
             tract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  history of any other malignant tumor disease&#xD;
&#xD;
          -  inability to provide consent&#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>Ali A Aghdassi, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medicine Greifswald</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medicine Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>January 22, 2023</last_update_submitted>
  <last_update_submitted_qc>January 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 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>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Bile Duct Neoplasms</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Intestinal Neoplasms</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/NCT04476082
org study id: BB 071/20
nct id: NCT04476082
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Malnutrition and loss of muscle mass frequently occur in patients undergoing chemotherapy and
      can negatively effect therapy outcome. Especially patients with cancer of the
      gastrointestinal tract are often affected by malnutrition. Therefore, this study aims to
      examine changes in nutritional status of patients with cancer of the gastrointestinal tract
      during chemotherapy. Findings of this study will help to improve nutritional treatment of
      patients undergoing chemotherapy.
Malnutrition and sarcopenia are common complications in patients with malignant diseases of
      the gastrointestinal tract. During chemotherapy there is a high risk of further impairment of
      nutritional status due to anorexia, nausea, emesis and other gastrointestinal conditions that
      adversely impact food assimilation or absorption. Findings on changes of nutritional status
      during chemotherapy are scarce but of paramount importance for adequate nutrition therapy.
      Therefore, this study aims to provide a detailed description of changes in nutritional status
      of patients with a malignant condition of the gastrointestinal tract during chemotherapy.
observational model: Other
time perspective: Prospective
measure: Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria)
time frame: 3 months after study enrollment
description: Change in prevalence of malnutrition according to the GLIM criteria
measure: Prevalence of Malnutrition According to the European Society for Clinical Nutrition and Metabolism criteria (ESPEN criteria)
time frame: 3 months after study enrollment
description: Change in prevalence of malnutrition according to the ESPEN criteria
measure: Skeletal Muscle Mass
time frame: 3 months after study enrollment
description: Changes in the skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)
measure: Fat Free Mass
time frame: 3 months after study enrollment
description: Changes in the fat free mass measured by Bioelectrical Impedance Analysis (BIA)
measure: Fat Mass
time frame: 3 months after study enrollment
description: Changes in the fat mass measured by Bioelectrical Impedance Analysis (BIA)
measure: Total Body Water
time frame: 3 months after study enrollment
description: Changes in the total Body water measured by Bioelectrical Impedance Analysis (BIA)
measure: Extracellular Water
time frame: 3 months after study enrollment
description: Changes in the total extracellular water measured by Bioelectrical Impedance Analysis (BIA)
measure: Phase Angle
time frame: 3 months after study enrollment
description: Changes in the phase angle measured by Bioelectrical Impedance Analysis (BIA)
measure: Body Weight
time frame: 3 months after study enrollment
description: Changes in body weight measured in kilograms
measure: Height
time frame: 3 months after study enrollment
description: Changes in height measured in meters
measure: Body Mass Index
time frame: 3 months after study enrollment
description: Changes in body mass index in kg/m^2 (calculated from the values obtained for body weight and height)
measure: Waist Circumference
time frame: 3 months after study enrollment
description: Changes in waist circumference measured in centimeters
measure: Hip Circumference
time frame: 3 months after study enrollment
description: Changes in hip circumference measured in centimeters
measure: Waist-to-Hip Ratio
time frame: 3 months after study enrollment
description: Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)
measure: Upper Arm Circumference
time frame: 3 months after study enrollment
description: Changes in upper arm circumference measured in centimeters
measure: Triceps Skinfold Thickness
time frame: 3 months after study enrollment
description: Changes in triceps skinfold thickness measured in millimeters
measure: Muscle Strength
time frame: 3 months after study enrollment
description: Changes in muscle strength measured by a handgrip strength dynamometer
measure: Muscle Function
time frame: 3 months after study enrollment
description: Changes in muscle function measured by a 4-m gait speed test
measure: Sarcopenia According to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria)
time frame: 3 months after study enrollment
description: Change in prevalence of sarcopenia according to the EWGSOP2 criteria
measure: Energy Intake
time frame: 3 months after study enrollment
description: Changes in energy intake assessed by 3-day weighed dietary record
measure: Protein Intake
time frame: 3 months after study enrollment
description: Changes in protein intake (in g/day) assessed by 3-day weighed dietary record
measure: Carbohydrate Intake
time frame: 3 months after study enrollment
description: Changes in carbohydrate intake (in g/day) assessed by 3-day weighed dietary record
measure: Fat Intake
time frame: 3 months after study enrollment
description: Changes in fat intake (in g/day) assessed by 3-day weighed dietary record
measure: Dietary Fiber Intake
time frame: 3 months after study enrollment
description: Changes in dietary fiber intake (in g/day) assessed by 3-day weighed dietary record
measure: Physical Activity
time frame: 3 months after study enrollment
description: Changes in metabolic equivalent of task per day and activity level are assessed by employment of the German version of the International Physical Activity Questionnaire (IPAQ) Short Form
measure: Complete Blood Count
time frame: 3 months after study enrollment
description: Changes in complete blood count
measure: Albumin
time frame: 3 months after study enrollment
description: Changes in plasma concentration of albumin
measure: Aspartate Transaminase
time frame: 3 months after study enrollment
description: Changes in plasma concentration of aspartate transferase
measure: Alanine Aminotransferase
time frame: 3 months after study enrollment
description: Changes in plasma concentration of alanine aminotransferase
measure: Gamma-glutamyl Transferase
time frame: 3 months after study enrollment
description: Changes in plasma concentration of gamma-glutamyl transferase
measure: Bilirubin
time frame: 3 months after study enrollment
description: Changes in plasma concentration of bilirubin
measure: Creatinine
time frame: 3 months after study enrollment
description: Changes in plasma concentration of creatinine
measure: Urea
time frame: 3 months after study enrollment
description: Changes in plasma concentration of urea
measure: C-reactive Protein
time frame: 3 months after study enrollment
description: Changes in plasma concentration of C-reactive protein
measure: Plasma Metabolome
time frame: 3 months after study enrollment
description: Changes in plasma metabolome
measure: Plasma Transcriptome
time frame: 3 months after study enrollment
description: Changes in plasma transcriptome
measure: Intestinal Microbiome
time frame: 3 months after study enrollment
description: Changes in intestinal microbiome
arm group label: Initial Diagnosis
description: Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment.
arm group label: Ongoing Cytostatic Treatment
description: Patients with a malignant condition of the gastrointestinal tract already receiving cytostatic treatment.
intervention type: Other
intervention name: No intervention - observational study only
description: No intervention - observational study only
arm group label: Initial Diagnosis
arm group label: Ongoing Cytostatic Treatment
Blood Plasma, Faeces
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ali A Aghdassi, Professor
role: Principal Investigator
affiliation: University Medicine Greifswald
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors
mesh term: Bile Duct Neoplasms
mesh term: Cholangiocarcinoma
mesh term: Intestinal Neoplasms