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/NCT06039306</url>
    </required_header>
    <id_info>
      <org_study_id>RSCH ID-22-04215-WHE</org_study_id>
      <nct_id>NCT06039306</nct_id>
    </id_info>
    <brief_title>Perioperative Immunonutrition Under Enhanced Recovery After Surgery</brief_title>
    <acronym>PING-ERAS</acronym>
    <official_title>Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universiti Putra Malaysia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universiti Putra Malaysia</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 goal of this clinical trial is to compare the effect of perioperative immunonutrition&#xD;
        supplement in gynecologic cancer patients. The main questions it aims to answer are:&#xD;
  &#xD;
          -  is there any difference in the nutritional outcomes and functional outcomes between&#xD;
             intervention and conventional groups?&#xD;
  &#xD;
          -  is there any difference in the post-surgical outcomes between intervention and&#xD;
             conventional groups?&#xD;
  &#xD;
        Participants (intervention) will be provided the immunonutrition supplement before and after&#xD;
        operation.&#xD;
  &#xD;
        Researchers will compare intervention group with conventional group to see if there is any&#xD;
        difference in postoperative outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The clinical trial aims to determine the effectiveness of perioperative IMN intervention on&#xD;
        postoperative outcomes among GC patients under Enhanced Recovery after Surgery (ERAS)&#xD;
        setting. Patients will prescribed with immunonutrition supplement before and after surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>
      <intervention_model_description>After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>daily energy and protein intake</measure>
      <time_frame>1 month</time_frame>
      <description>24-hours diet recall</description>
    </primary_outcome>
    <primary_outcome>
      <measure>body composition</measure>
      <time_frame>1 month</time_frame>
      <description>body composition analyzer; weight in kg; fat free mass in kg; fat mass in kg; muscle mass in kg; height in meter</description>
    </primary_outcome>
    <primary_outcome>
      <measure>immunoglobulin level</measure>
      <time_frame>1 month</time_frame>
      <description>Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M</description>
    </primary_outcome>
    <primary_outcome>
      <measure>C-reactive protein</measure>
      <time_frame>1 month</time_frame>
      <description>Concentration of C-reactive protein</description>
    </primary_outcome>
    <primary_outcome>
      <measure>postoperative outcomes</measure>
      <time_frame>1 months</time_frame>
      <description>length of hospitalization</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Functional status</measure>
      <time_frame>1 month</time_frame>
      <description>handgrip strength in kg via Jammar dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>stress level</measure>
      <time_frame>1 month</time_frame>
      <description>questionnaire 10-item perceived stress scale (PSS-10) form</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">106</enrollment>
    <condition>Gynecological Cancer</condition>
    <condition>Elective Surgery</condition>
    <arm_group>
      <arm_group_label>intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be given 2 servings immunonutrition daily for five (5) days before tentative elective surgery. ERAS protocol will implement and continued 2 servings of immunonutrition for post-operative seven (7) days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>conventional</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants will be on usual diet intake before tentative elective surgery. ERAS protocol will implement and will be prescribed 2 servings of polymeric formula daily only if unable to finish 75% of the diet served in ward.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Immunonutrition oral nutrition supplementation</intervention_name>
      <description>Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery</description>
      <arm_group_label>intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Those who diagnosed with GC&#xD;
  &#xD;
            2. Candidates for elective operation treatments&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Those are involved gastrointestinal tract (complication)&#xD;
  &#xD;
            2. Those are diagnosed with GC (metastasis)&#xD;
  &#xD;
            3. Allergy to milk/soy/whey protein&#xD;
  &#xD;
            4. Participate in other intervention study&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ChiouYi Ho</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Cancer Institute, Malaysia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ChiouYi Ho</last_name>
      <phone>0388925555</phone>
      <phone_ext>3404</phone_ext>
      <email>agneshcy0326@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zulfitri 'Azuan Mat Daud</last_name>
      <email>zulfitri@upm.edu.my</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institut Kanser Negara (National Cancer Institute)</name>
        <address>
          <city>Putrajaya</city>
          <zip>62250</zip>
          <country>Malaysia</country>
        </address>
      </facility>
      <contact>
        <last_name>ChiouYi Ho</last_name>
        <phone>0127603622</phone>
        <phone_ext>3404</phone_ext>
        <email>agneshcy0326@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Malaysia</country>
    </location_countries>
    <results_reference>
      <citation>Hertlein L, Zeder-Goss C, Furst S, Bayer D, Trillsch F, Czogalla B, Mahner S, Burges A, Rittler P. Peri-operative oral immunonutrition in malnourished ovarian cancer patients assessed by the nutritional risk screening. Arch Gynecol Obstet. 2018 Jun;297(6):1533-1538. doi: 10.1007/s00404-018-4759-8. Epub 2018 Apr 5.</citation>
      <PMID>29623417</PMID>
    </results_reference>
    <results_reference>
      <citation>Abeles A, Kwasnicki RM, Darzi A. Enhanced recovery after surgery: Current research insights and future direction. World J Gastrointest Surg. 2017 Feb 27;9(2):37-45. doi: 10.4240/wjgs.v9.i2.37.</citation>
      <PMID>28289508</PMID>
    </results_reference>
    <results_reference>
      <citation>Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.</citation>
      <PMID>27637832</PMID>
    </results_reference>
    <results_reference>
      <citation>Ho CY, Ibrahim Z, Abu Zaid Z, Mat Daud ZA, Mohd Yusop NB, Mohd Abas MN, Omar J. Postoperative Dietary Intake Achievement: A Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2022 Jan 5;14(1):222. doi: 10.3390/nu14010222.</citation>
      <PMID>35011097</PMID>
    </results_reference>
    <results_reference>
      <citation>Yi HC, Ibrahim Z, Abu Zaid Z, Mat Daud Z', Md Yusop NB, Omar J, Mohd Abas MN, Abdul Rahman Z, Jamhuri N. Impact of Enhanced Recovery after Surgery with Preoperative Whey Protein-Infused Carbohydrate Loading and Postoperative Early Oral Feeding among Surgical Gynecologic Cancer Patients: An Open-Labelled Randomized Controlled Trial. Nutrients. 2020 Jan 20;12(1):264. doi: 10.3390/nu12010264.</citation>
      <PMID>31968595</PMID>
    </results_reference>
    <results_reference>
      <citation>Mudge LA, Watson DI, Smithers BM, Isenring EA, Smith L, Jamieson GG; Australian Immunonutrition Study Group. Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer. Br J Surg. 2018 Sep;105(10):1262-1272. doi: 10.1002/bjs.10923. Epub 2018 Jul 12.</citation>
      <PMID>29999517</PMID>
    </results_reference>
    <results_reference>
      <citation>Di Renzo L, De Lorenzo A, Fontanari M, Gualtieri P, Monsignore D, Schifano G, Alfano V, Marchetti M; SIERR. Immunonutrients involved in the regulation of the inflammatory and oxidative processes: implication for gamete competence. J Assist Reprod Genet. 2022 Apr;39(4):817-846. doi: 10.1007/s10815-022-02472-6. Epub 2022 Mar 30.</citation>
      <PMID>35353297</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universiti Putra Malaysia</investigator_affiliation>
      <investigator_full_name>ChiouYi Ho</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>gynecological cancer, elective surgery</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06039306
  org study id: RSCH ID-22-04215-WHE
  nct id: NCT06039306
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the effect of perioperative immunonutrition
        supplement in gynecologic cancer patients. The main questions it aims to answer are:
  
          -  is there any difference in the nutritional outcomes and functional outcomes between
             intervention and conventional groups?
  
          -  is there any difference in the post-surgical outcomes between intervention and
             conventional groups?
  
        Participants (intervention) will be provided the immunonutrition supplement before and after
        operation.
  
        Researchers will compare intervention group with conventional group to see if there is any
        difference in postoperative outcomes.
  The clinical trial aims to determine the effectiveness of perioperative IMN intervention on
        postoperative outcomes among GC patients under Enhanced Recovery after Surgery (ERAS)
        setting. Patients will prescribed with immunonutrition supplement before and after surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: daily energy and protein intake
  time frame: 1 month
  description: 24-hours diet recall
  measure: body composition
  time frame: 1 month
  description: body composition analyzer; weight in kg; fat free mass in kg; fat mass in kg; muscle mass in kg; height in meter
  measure: immunoglobulin level
  time frame: 1 month
  description: Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M
  measure: C-reactive protein
  time frame: 1 month
  description: Concentration of C-reactive protein
  measure: postoperative outcomes
  time frame: 1 months
  description: length of hospitalization
  measure: Functional status
  time frame: 1 month
  description: handgrip strength in kg via Jammar dynamometer
  measure: stress level
  time frame: 1 month
  description: questionnaire 10-item perceived stress scale (PSS-10) form
  arm group label: intervention
  arm group type: Experimental
  description: Participants will be given 2 servings immunonutrition daily for five (5) days before tentative elective surgery. ERAS protocol will implement and continued 2 servings of immunonutrition for post-operative seven (7) days.
  arm group label: conventional
  arm group type: No Intervention
  description: Participants will be on usual diet intake before tentative elective surgery. ERAS protocol will implement and will be prescribed 2 servings of polymeric formula daily only if unable to finish 75% of the diet served in ward.
  intervention type: Dietary Supplement
  intervention name: Immunonutrition oral nutrition supplementation
  description: Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery
  arm group label: intervention
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: ChiouYi Ho
  role: Principal Investigator
  affiliation: National Cancer Institute, Malaysia
  last name: ChiouYi Ho
  phone: 0388925555
  phone ext: 3404
  email: agneshcy0326@gmail.com
  last name: Zulfitri 'Azuan Mat Daud
  email: zulfitri@upm.edu.my
  facility: 
  contact: 
  country: Malaysia
  citation: Hertlein L, Zeder-Goss C, Furst S, Bayer D, Trillsch F, Czogalla B, Mahner S, Burges A, Rittler P. Peri-operative oral immunonutrition in malnourished ovarian cancer patients assessed by the nutritional risk screening. Arch Gynecol Obstet. 2018 Jun;297(6):1533-1538. doi: 10.1007/s00404-018-4759-8. Epub 2018 Apr 5.
  PMID: 29623417
  citation: Abeles A, Kwasnicki RM, Darzi A. Enhanced recovery after surgery: Current research insights and future direction. World J Gastrointest Surg. 2017 Feb 27;9(2):37-45. doi: 10.4240/wjgs.v9.i2.37.
  PMID: 28289508
  citation: Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.
  PMID: 27637832
  citation: Ho CY, Ibrahim Z, Abu Zaid Z, Mat Daud ZA, Mohd Yusop NB, Mohd Abas MN, Omar J. Postoperative Dietary Intake Achievement: A Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2022 Jan 5;14(1):222. doi: 10.3390/nu14010222.
  PMID: 35011097
  citation: Yi HC, Ibrahim Z, Abu Zaid Z, Mat Daud Z', Md Yusop NB, Omar J, Mohd Abas MN, Abdul Rahman Z, Jamhuri N. Impact of Enhanced Recovery after Surgery with Preoperative Whey Protein-Infused Carbohydrate Loading and Postoperative Early Oral Feeding among Surgical Gynecologic Cancer Patients: An Open-Labelled Randomized Controlled Trial. Nutrients. 2020 Jan 20;12(1):264. doi: 10.3390/nu12010264.
  PMID: 31968595
  citation: Mudge LA, Watson DI, Smithers BM, Isenring EA, Smith L, Jamieson GG; Australian Immunonutrition Study Group. Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer. Br J Surg. 2018 Sep;105(10):1262-1272. doi: 10.1002/bjs.10923. Epub 2018 Jul 12.
  PMID: 29999517
  citation: Di Renzo L, De Lorenzo A, Fontanari M, Gualtieri P, Monsignore D, Schifano G, Alfano V, Marchetti M; SIERR. Immunonutrients involved in the regulation of the inflammatory and oxidative processes: implication for gamete competence. J Assist Reprod Genet. 2022 Apr;39(4):817-846. doi: 10.1007/s10815-022-02472-6. Epub 2022 Mar 30.
  PMID: 35353297
  responsible party type: Principal Investigator
  investigator affiliation: Universiti Putra Malaysia
  investigator full name: ChiouYi Ho
  investigator title: Principal Investigator
  sharing ipd: Undecided