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/NCT05980624</url>
    </required_header>
    <id_info>
      <org_study_id>FMBSUREC/09072023/Rabie</org_study_id>
      <nct_id>NCT05980624</nct_id>
    </id_info>
    <brief_title>ONS in Gastrointestinal Cancer Patients Undergoing Chemotherapy</brief_title>
    <official_title>The Impact of Oral Nutrition Supplements on the Clinical Outcomes in Gastrointestinal Cancer Patients Undergoing Chemotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</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>
        The study hypothesizes that the addition of oral nutrition supplement concurrent chemotherapy&#xD;
        treatment to the GI cancer patients will improve the prognosis of cancer cachexia, improve&#xD;
        health state quality of life and increase chemotherapy tolerance&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Malnutrition is a major public health issue in low- and middle-income countries and forms&#xD;
        part of the United Nations 2030 Agenda for Sustainable Development Goals .Cancer is a&#xD;
        systemic disease, since even in the early stages malignancies are accompanied by homeostatic&#xD;
        imbalance, including metabolic deregulation and increased catabolism. These abnormalities may&#xD;
        initially seem poorly discernible in the clinic, but with disease progression they may&#xD;
        aggravate; and may cause overt cancer-related cachexia.GI cancers show higher mortality than&#xD;
        any other kind of cancer. In 2020, they accounted for an estimated 3.5 million deaths&#xD;
        worldwide, with a further 5.0 million new cases diagnosed in the same year . Colorectal&#xD;
        cancer (CRC) is the most common type of GI cancer, being the third most common of all organ&#xD;
        cancers after lung and breast cancers, whereas gastric, liver, esophageal, and pancreatic&#xD;
        cancers are ranked the fifth, sixth, eighth, and 12th most commonly diagnosed cancers,&#xD;
        respectively&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Body Composition</measure>
      <time_frame>3 month</time_frame>
      <description>measured by DEXA OR BIA</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anthropometric measures</measure>
      <time_frame>3 month</time_frame>
      <description>Body mass index change</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)</measure>
      <time_frame>3 MONTHS</time_frame>
      <description>malnutrition assessment tool. ( 0-1 )No intervention required at this time. Re-assessment on routine and regular basis during treatment.&#xD;
  (2-3) Patient &amp; family education by dietitian, nurse, or other clinician with pharmacologic intervention as indicated by symptom survey and lab values as appropriate. (4-8) Requires intervention by dietitian, in conjunction with nurse or physician as indicated by symptoms .&#xD;
  9 Indicates a critical need for improved symptom management and/or nutrient intervention options</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Laboratory data values mean and standard deviation</measure>
      <time_frame>3 months</time_frame>
      <description>Albumin and CRP ,total protein</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>overall response rate</measure>
      <time_frame>6 months</time_frame>
      <description>complete response or progression and regression percentage of participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>common adverse effects</measure>
      <time_frame>6 months</time_frame>
      <description>Git toxicity , hematologic toxicity</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Gastrointestinal Cancer</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>oral nutrition supplement</intervention_name>
      <description>patients receive ONS 300kcal in daily basis</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          GI cancer patients will be included in the study if they meet the following criteria:&#xD;
  &#xD;
            1. Confirmed cancer diagnosis any stage or metastatic confirmed by radiological and&#xD;
               pathological or by clinical evaluation receiving neo/adjuvant chemotherapy treatment.&#xD;
  &#xD;
            2. Age above 18 years old&#xD;
  &#xD;
            3. Be accessible for chemotherapy treatment and follow-up&#xD;
  &#xD;
            4. Availability to administer oral supplements&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2&#xD;
  &#xD;
            6. Life expectancy ≥3 months.&#xD;
  &#xD;
            7. Written informed consent according to the local Ethics Committee requirements&#xD;
  &#xD;
            8. Willing to fill Nutrition questionnaires.&#xD;
  &#xD;
            9. Negative pregnancy test for pre-menopausal women before inclusion in the trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patients will be excluded from the study if they have the following criteria:&#xD;
  &#xD;
                 1. Known hypersensitivity reaction to the investigational compounds or incorporated&#xD;
                    substances&#xD;
  &#xD;
                 2. patients who are unlikely to comply with trial requirements (eg, confusion,&#xD;
                    psychological or mood disturbances ,alcoholism)&#xD;
  &#xD;
                 3. Pregnancy or lactating&#xD;
  &#xD;
                 4. Medical or psychological condition which in the opinion of the investigator would&#xD;
                    not permit the patient to complete the study or sign meaningful informed consent&#xD;
  &#xD;
                 5. Age &lt; 18 years&#xD;
  &#xD;
                 6. Indication to or ongoing artificial nutrition support (totally compromised&#xD;
                    spontaneous food-intake) and incapacity or unavailability to consume ONS&#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>Alshaimaa Rabie</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beni-Suef University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alshaimaa Rabie</last_name>
      <phone>01061263030</phone>
      <email>alshaimaa.ph@o6u.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beni suef university hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alshaimaa Ibrahim Rabie</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>ALshaimaa Ibrahim Rabie</investigator_full_name>
      <investigator_title>Clinical nutrition pharmacist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastrointestinal 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/NCT05980624
  org study id: FMBSUREC/09072023/Rabie
  nct id: NCT05980624
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study hypothesizes that the addition of oral nutrition supplement concurrent chemotherapy
        treatment to the GI cancer patients will improve the prognosis of cancer cachexia, improve
        health state quality of life and increase chemotherapy tolerance
  Malnutrition is a major public health issue in low- and middle-income countries and forms
        part of the United Nations 2030 Agenda for Sustainable Development Goals .Cancer is a
        systemic disease, since even in the early stages malignancies are accompanied by homeostatic
        imbalance, including metabolic deregulation and increased catabolism. These abnormalities may
        initially seem poorly discernible in the clinic, but with disease progression they may
        aggravate; and may cause overt cancer-related cachexia.GI cancers show higher mortality than
        any other kind of cancer. In 2020, they accounted for an estimated 3.5 million deaths
        worldwide, with a further 5.0 million new cases diagnosed in the same year . Colorectal
        cancer (CRC) is the most common type of GI cancer, being the third most common of all organ
        cancers after lung and breast cancers, whereas gastric, liver, esophageal, and pancreatic
        cancers are ranked the fifth, sixth, eighth, and 12th most commonly diagnosed cancers,
        respectively
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Body Composition
  time frame: 3 month
  description: measured by DEXA OR BIA
  measure: Anthropometric measures
  time frame: 3 month
  description: Body mass index change
  measure: Nutrition status - scored Patient-Generated Subjective Global Assessment (PG-SGA)
  time frame: 3 MONTHS
  description: malnutrition assessment tool. ( 0-1 )No intervention required at this time. Re-assessment on routine and regular basis during treatment.
  (2-3) Patient & family education by dietitian, nurse, or other clinician with pharmacologic intervention as indicated by symptom survey and lab values as appropriate. (4-8) Requires intervention by dietitian, in conjunction with nurse or physician as indicated by symptoms .
  9 Indicates a critical need for improved symptom management and/or nutrient intervention options
  measure: Laboratory data values mean and standard deviation
  time frame: 3 months
  description: Albumin and CRP ,total protein
  measure: overall response rate
  time frame: 6 months
  description: complete response or progression and regression percentage of participants
  measure: common adverse effects
  time frame: 6 months
  description: Git toxicity , hematologic toxicity
  arm group label: Group A
  arm group type: No Intervention
  description: nutrition counselling plus Standard chemotherapy only. Patients will undergo only standard chemotherapy for 3 months
  arm group label: Group B
  arm group type: Experimental
  description: nutrition counselling plus standard chemotherapy adding oral nutrition supplements as described in manufacturer label daily for 3 month and
  intervention type: Dietary Supplement
  intervention name: oral nutrition supplement
  description: patients receive ONS 300kcal in daily basis
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alshaimaa Rabie
  role: Principal Investigator
  affiliation: Beni-Suef University
  last name: Alshaimaa Rabie
  phone: 01061263030
  email: alshaimaa.ph@o6u.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: ALshaimaa Ibrahim Rabie
  investigator title: Clinical nutrition pharmacist
  mesh term: Gastrointestinal Neoplasms
  sharing ipd: No