xml: <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/NCT06022770</url>
    </required_header>
    <id_info>
      <org_study_id>HunanCH-50</org_study_id>
      <nct_id>NCT06022770</nct_id>
    </id_info>
    <brief_title>Clinical Study on Nutrition Intervention in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy</brief_title>
    <official_title>Clinical Study on Nutrition Intervention to Improve Nutrition and Quality of Life in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hunan Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Third Xiangya Hospital of Central South University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hunan Cancer Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as&#xD;
        research objects to conduct nutritional risk screening, malnutrition assessment and quality&#xD;
        of life assessment. They were randomized into the nutrition counseling group (NC) and the&#xD;
        nutrition support therapy group (NST). To evaluate the nutrition and life quality of patients&#xD;
        with esophageal cancer and gastric cancer before and after chemotherapy, and to study the&#xD;
        effects of nutritional support therapy on nutrition and life quality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In view of the high incidence of malnutrition in esophageal cancer and gastric cancer and&#xD;
        chemotherapy may further aggravate malnutrition and reduce quality of life. According to the&#xD;
        inclusion criteria, 280 patients with esophageal cancer and gastric cancer undergoing&#xD;
        chemotherapy were selected as research objects to conduct nutritional risk screening,&#xD;
        malnutrition assessment and quality of life assessment. They were randomized into the&#xD;
        nutrition counseling group (NC) and the nutrition support therapy group (NST). To evaluate&#xD;
        the nutrition and life quality of patients with esophageal cancer and gastric cancer before&#xD;
        and after chemotherapy, and to study the effects of nutritional support therapy on nutrition&#xD;
        and life quality; On this basis, a nutrition and life quality management system for patients&#xD;
        with tubular upper digestive tract chemotherapy tumors was constructed, and the system was&#xD;
        objectively evaluated from the clinical point of view, so as to provide a feasible scheme for&#xD;
        improving the nutrition and life quality of patients with tubular upper digestive tract&#xD;
        chemotherapy tumors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
    <phase>N/A</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>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Nutritional risk screening（NRS） 2002 scale</measure>
      <time_frame>Nutritional risk screening（NRS） 2002 scale during day 1 and day 42</time_frame>
      <description>Nutritional risk screening（NRS） 2002 scale of patients with esophageal and gastric cancer before and after chemotherapy. The score includes 0,1,2,3,4,5,6 and 7.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>rates of malnutrition of patients</measure>
      <time_frame>rates of malnutrition of patients during day 1 and day 42</time_frame>
      <description>Rates of malnutrition of patients with esophageal and gastric cancer before and after chemotherapy. The result is shown as &quot;percent&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>quality of life of patients with esophageal and gastric cancer before and after chemotherapy</measure>
      <time_frame>rates of quality of life of patients during day 1 and day 42</time_frame>
      <description>quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D (score of 0-1）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>quality of life of patients with esophageal and gastric cancer before and after chemotherapy</measure>
      <time_frame>rates of quality of life of patients during day 1 and day 42</time_frame>
      <description>quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D VAS (score of 1-100）</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Nutrition Aspect of Cancer</condition>
    <arm_group>
      <arm_group_label>Nutritional Counseling</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Nutrition Support Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Nutritional counseling，Enteral Nutrition</intervention_name>
      <description>patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as the study objects for nutritional risk screening, malnutrition assessment and quality of life assessment. Randomly enter the nutrition consultation group (NC) and nutrition support treatment group (NST)</description>
      <arm_group_label>Nutrition Support Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Esophageal or gastric cancer confirmed by histology or cytology;&#xD;
  &#xD;
            -  Age 18-75 years old, gender unlimited;&#xD;
  &#xD;
            -  Blood routine: hemoglobin ≥90g/L, absolute neutrophil count (ANC) ≥1.5×109/L,&#xD;
               platelets ≥100×109/L; (2) Liver and kidney function: alanine transaminase（ALT）,&#xD;
               glutamic-oxalacetic transaminease（AST）≤2.5 times the normal upper limit (with liver&#xD;
               metastasis ≤5 times the normal upper limit); ALP≤2.5 times the normal upper limit (≤5&#xD;
               times the normal upper limit for patients with liver or bone metastasis); Serum total&#xD;
               bilirubin (TBIL) was less than 1.5 times the normal upper limit. Serum creatinine&#xD;
               (SCr) &lt; 1.5 times the upper limit of normal; ③ Blood biochemistry: Serum albumin (ALB)&#xD;
               ≥30g/L;&#xD;
  &#xD;
            -  Predicted survival of more than 3 months; It is planned to continue chemotherapy for&#xD;
               &gt;3 cycles in the hospital or outpatient department&#xD;
  &#xD;
            -  All patients participated in this study voluntarily and signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other tumors, including pancreatic cancer, liver cancer and other solid digestive&#xD;
               tract tumors, colon cancer, rectal cancer and other tubular lower digestive tract&#xD;
               tumors;&#xD;
  &#xD;
            -  Have serious heart, lung and brain diseases; Complicated with chronic hepatitis,&#xD;
               cirrhosis, chronic nephritis, renal insufficiency, etc.&#xD;
  &#xD;
            -  Fever associated with infection; Have difficult-to-control diabetes or other metabolic&#xD;
               diseases;&#xD;
  &#xD;
            -  Patients with unstable vital signs and multiple organ failure;&#xD;
  &#xD;
            -  The patient has poor cognitive ability and is unable to answer questions or fill out&#xD;
               questionnaires.&#xD;
  &#xD;
            -  The investigator believes that the subjects have a history of other serious systemic&#xD;
               diseases or are not suitable for participating in this clinical study for other&#xD;
               reasons&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 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>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022770
  org study id: HunanCH-50
  nct id: NCT06022770
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as
        research objects to conduct nutritional risk screening, malnutrition assessment and quality
        of life assessment. They were randomized into the nutrition counseling group (NC) and the
        nutrition support therapy group (NST). To evaluate the nutrition and life quality of patients
        with esophageal cancer and gastric cancer before and after chemotherapy, and to study the
        effects of nutritional support therapy on nutrition and life quality.
  In view of the high incidence of malnutrition in esophageal cancer and gastric cancer and
        chemotherapy may further aggravate malnutrition and reduce quality of life. According to the
        inclusion criteria, 280 patients with esophageal cancer and gastric cancer undergoing
        chemotherapy were selected as research objects to conduct nutritional risk screening,
        malnutrition assessment and quality of life assessment. They were randomized into the
        nutrition counseling group (NC) and the nutrition support therapy group (NST). To evaluate
        the nutrition and life quality of patients with esophageal cancer and gastric cancer before
        and after chemotherapy, and to study the effects of nutritional support therapy on nutrition
        and life quality; On this basis, a nutrition and life quality management system for patients
        with tubular upper digestive tract chemotherapy tumors was constructed, and the system was
        objectively evaluated from the clinical point of view, so as to provide a feasible scheme for
        improving the nutrition and life quality of patients with tubular upper digestive tract
        chemotherapy tumors.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Nutritional risk screening（NRS） 2002 scale
  time frame: Nutritional risk screening（NRS） 2002 scale during day 1 and day 42
  description: Nutritional risk screening（NRS） 2002 scale of patients with esophageal and gastric cancer before and after chemotherapy. The score includes 0,1,2,3,4,5,6 and 7.
  measure: rates of malnutrition of patients
  time frame: rates of malnutrition of patients during day 1 and day 42
  description: Rates of malnutrition of patients with esophageal and gastric cancer before and after chemotherapy. The result is shown as "percent".
  measure: quality of life of patients with esophageal and gastric cancer before and after chemotherapy
  time frame: rates of quality of life of patients during day 1 and day 42
  description: quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D (score of 0-1）
  measure: quality of life of patients with esophageal and gastric cancer before and after chemotherapy
  time frame: rates of quality of life of patients during day 1 and day 42
  description: quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D VAS (score of 1-100）
  arm group label: Nutritional Counseling
  arm group type: No Intervention
  arm group label: Nutrition Support Therapy
  arm group type: Experimental
  intervention type: Dietary Supplement
  intervention name: Nutritional counseling，Enteral Nutrition
  description: patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as the study objects for nutritional risk screening, malnutrition assessment and quality of life assessment. Randomly enter the nutrition consultation group (NC) and nutrition support treatment group (NST)
  arm group label: Nutrition Support Therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Stomach Neoplasms
  sharing ipd: No