<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/NCT04400552</url>
  </required_header>
  <id_info>
    <org_study_id>IMU R204/2017</org_study_id>
    <nct_id>NCT04400552</nct_id>
  </id_info>
  <brief_title>Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients</brief_title>
  <official_title>Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients- A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kotra Pharma (M) Sdn Bhd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Medical 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 aim of this study is to evaluate the effectiveness of perioperative oral nutrition&#xD;
      supplementation (ONS) on nutritional status in malnourished cancer patients undergoing&#xD;
      elective surgery.&#xD;
&#xD;
      The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is&#xD;
      effective on improving nutritional status. An extended period of 3 months post-operative ONS&#xD;
      feeding is effective on improving nutritional status as compared to ONS feeding&#xD;
      post-operatively during hospital stay only. Perioperative feeding is effective on improving&#xD;
      secondary outcomes such as sleep quality, post-operative complications and length of hospital&#xD;
      stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this study is to evaluate the effectiveness of perioperative oral&#xD;
      nutrition supplementation (ONS) on nutritional status in malnourished cancer patients&#xD;
      undergoing elective surgery.&#xD;
&#xD;
      The specific objectives are:&#xD;
&#xD;
        1. To evaluate the baseline nutritional status of cancer patients undergoing elective&#xD;
           surgery&#xD;
&#xD;
        2. To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in&#xD;
           malnourished surgical cancer patients&#xD;
&#xD;
        3. To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after&#xD;
           discharge versus ONS feeding only post-operatively during hospital on nutritional status&#xD;
&#xD;
        4. To evaluate secondary outcomes of perioperative feeding such as sleep quality,&#xD;
           post-operative complications and length of hospital stay&#xD;
&#xD;
      Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will&#xD;
      be conducted on malnourished cancer patients undergoing elective surgery.&#xD;
&#xD;
      Study duration: The participation duration for each participant is 4 months. The completion&#xD;
      of the study will take around 30 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 26, 2018</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Change from baseline body weight at 4 months</time_frame>
    <description>Anthropometry measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body mass index (BMI)</measure>
    <time_frame>Change from baseline body mass index (BMI) at 4 months</time_frame>
    <description>Anthropometry measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum albumin level</measure>
    <time_frame>Change from baseline serum albumin level at 4 months</time_frame>
    <description>Serum albumin is an indicator of protein stores to assess nutritional status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum pre-albumin level</measure>
    <time_frame>Change from baseline serum pre-albumin level at 4 months</time_frame>
    <description>Serum pre-albumin is an indicator of protein stores to assess nutritional status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in handgrip force</measure>
    <time_frame>Change from baseline handgrip force at 4 months</time_frame>
    <description>Handgrip force is a measure of handgrip strength by dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in muscle mass</measure>
    <time_frame>Change from baseline muscle mass at 4 months</time_frame>
    <description>Muscle mass reported in kilogram is measured by bioelectrical impedance analyser</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat mass</measure>
    <time_frame>Change from baseline fat mass at 4 months</time_frame>
    <description>Fat mass reported in kilogram is measured by bioelectrical impedance analyser</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum transferrin level</measure>
    <time_frame>Change from baseline serum transferrin level at 4 months</time_frame>
    <description>Serum transferrin is a measure of nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hemoglobin level</measure>
    <time_frame>Change from baseline hemoglobin level at 4 months</time_frame>
    <description>Serum hemoglobin is a measure of nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in high sensitivity c-reactive protein (HsCRP) level</measure>
    <time_frame>Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months</time_frame>
    <description>High sensitivity c-reactive protein (HsCRP) is a measure of inflammatory status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin-6 (IL-6)</measure>
    <time_frame>Change from baseline Interleukin-6 (IL-6) at 4 months</time_frame>
    <description>Interleukin-6 (IL-6) is a measure of inflammatory status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in salivary cortisol level</measure>
    <time_frame>Change from baseline salivary cortisol level at 4 months</time_frame>
    <description>Salivary cortisol level is a biological marker of stress reaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in energy intake</measure>
    <time_frame>Change from baseline energy intake at 4 months</time_frame>
    <description>Energy intake reported in calories is a dietary measure to assess nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in protein intake</measure>
    <time_frame>Change from baseline protein intake at 4 months</time_frame>
    <description>Protein intake reported in gram is a dietary measure to assess nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index (PSQI) scores</measure>
    <time_frame>Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI) scores range from 0-42.Higher scores indicate poorer sleep quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of post-surgical complications</measure>
    <time_frame>Change from baseline post-surgical complications at 3 months</time_frame>
    <description>Post-surgical complications are indicated by presence of wound infection, chest infection and use of antibiotics, responses are either yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>Number of days participants are admitted into the hospital</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Cancer of Breast</condition>
  <condition>Cancer Colon</condition>
  <arm_group>
    <arm_group_label>ONS Pre-op + ONS Post-op</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ONS Pre-op + ONS Post-op + ONS Post-op 3 months</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral nutrition supplementation (ONS) pre-operatively, post-operatively up to being discharged from hospital and an extended oral nutrition supplementation post-operatively up to 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual intake Pre-op + ONS Post-op</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Follow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ONS Pre-op + ONS Post-op</intervention_name>
    <description>Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital.</description>
    <arm_group_label>ONS Pre-op + ONS Post-op</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ONS Pre-op + ONS Post-op + ONS Post-op 3 months</intervention_name>
    <description>Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months.</description>
    <arm_group_label>ONS Pre-op + ONS Post-op + ONS Post-op 3 months</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Usual intake Pre-op + ONS Post-op</intervention_name>
    <description>Participants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital</description>
    <arm_group_label>Usual intake Pre-op + ONS Post-op</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female from all ethnicity&#xD;
&#xD;
          -  25 to 65 years&#xD;
&#xD;
          -  BMI not less than 18.0 kg/m²&#xD;
&#xD;
          -  Cancer patients who are confirmed with elective surgery whose co-morbidities are&#xD;
             stabilized based on the ASA Physical Status Classification System ASA Class 1 and 2&#xD;
&#xD;
          -  Fulfil at least two characteristics of AND/ ASPEN Diagnosis of Malnutrition These&#xD;
             characteristics are insufficient energy intake, weight loss, loss of muscle mass, loss&#xD;
             of subcutaneous fat, localized or generalized fluid accumulation and diminished&#xD;
             functional status as measured by handgrip strength.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who require enteral or parenteral feeding&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  On chemotherapy or radiotherapy&#xD;
&#xD;
          -  Total gastrectomy or ileostomy&#xD;
&#xD;
          -  Metastasized cancer, upper gastrointestinal cancer, terminal diseases, decompensated&#xD;
             liver or renal disease, major concurrent metabolic problem such as uncontrolled&#xD;
             diabetes, dementia&#xD;
&#xD;
          -  On regular steroids prescription&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Winnie SS Chee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Medical University</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>57000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>April 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>International Medical University</investigator_affiliation>
    <investigator_full_name>Winnie Chee</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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>


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/NCT04400552
org study id: IMU R204/2017
nct id: NCT04400552
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the effectiveness of perioperative oral nutrition
      supplementation (ONS) on nutritional status in malnourished cancer patients undergoing
      elective surgery.

      The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is
      effective on improving nutritional status. An extended period of 3 months post-operative ONS
      feeding is effective on improving nutritional status as compared to ONS feeding
      post-operatively during hospital stay only. Perioperative feeding is effective on improving
      secondary outcomes such as sleep quality, post-operative complications and length of hospital
      stay.
The main objective of this study is to evaluate the effectiveness of perioperative oral
      nutrition supplementation (ONS) on nutritional status in malnourished cancer patients
      undergoing elective surgery.

      The specific objectives are:

        1. To evaluate the baseline nutritional status of cancer patients undergoing elective
           surgery

        2. To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in
           malnourished surgical cancer patients

        3. To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after
           discharge versus ONS feeding only post-operatively during hospital on nutritional status

        4. To evaluate secondary outcomes of perioperative feeding such as sleep quality,
           post-operative complications and length of hospital stay

      Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will
      be conducted on malnourished cancer patients undergoing elective surgery.

      Study duration: The participation duration for each participant is 4 months. The completion
      of the study will take around 30 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in body weight
time frame: Change from baseline body weight at 4 months
description: Anthropometry measurement
measure: Change in body mass index (BMI)
time frame: Change from baseline body mass index (BMI) at 4 months
description: Anthropometry measurement
measure: Change in serum albumin level
time frame: Change from baseline serum albumin level at 4 months
description: Serum albumin is an indicator of protein stores to assess nutritional status
measure: Change in serum pre-albumin level
time frame: Change from baseline serum pre-albumin level at 4 months
description: Serum pre-albumin is an indicator of protein stores to assess nutritional status
measure: Change in handgrip force
time frame: Change from baseline handgrip force at 4 months
description: Handgrip force is a measure of handgrip strength by dynamometer
measure: Change in muscle mass
time frame: Change from baseline muscle mass at 4 months
description: Muscle mass reported in kilogram is measured by bioelectrical impedance analyser
measure: Change in fat mass
time frame: Change from baseline fat mass at 4 months
description: Fat mass reported in kilogram is measured by bioelectrical impedance analyser
measure: Change in serum transferrin level
time frame: Change from baseline serum transferrin level at 4 months
description: Serum transferrin is a measure of nutritional status
measure: Change in hemoglobin level
time frame: Change from baseline hemoglobin level at 4 months
description: Serum hemoglobin is a measure of nutritional status
measure: Change in high sensitivity c-reactive protein (HsCRP) level
time frame: Change from baseline high sensitivity c-reactive protein (HsCRP) level at 4 months
description: High sensitivity c-reactive protein (HsCRP) is a measure of inflammatory status
measure: Change in Interleukin-6 (IL-6)
time frame: Change from baseline Interleukin-6 (IL-6) at 4 months
description: Interleukin-6 (IL-6) is a measure of inflammatory status
measure: Change in salivary cortisol level
time frame: Change from baseline salivary cortisol level at 4 months
description: Salivary cortisol level is a biological marker of stress reaction
measure: Change in energy intake
time frame: Change from baseline energy intake at 4 months
description: Energy intake reported in calories is a dietary measure to assess nutritional status
measure: Change in protein intake
time frame: Change from baseline protein intake at 4 months
description: Protein intake reported in gram is a dietary measure to assess nutritional status
measure: Change in Pittsburgh Sleep Quality Index (PSQI) scores
time frame: Change from baseline Pittsburgh Sleep Quality Index (PSQI) scores at 4 months
description: Pittsburgh Sleep Quality Index (PSQI) scores range from 0-42.Higher scores indicate poorer sleep quality
measure: Presence of post-surgical complications
time frame: Change from baseline post-surgical complications at 3 months
description: Post-surgical complications are indicated by presence of wound infection, chest infection and use of antibiotics, responses are either yes or no
measure: Length of hospital stay
time frame: Up to 5 days
description: Number of days participants are admitted into the hospital
arm group label: ONS Pre-op + ONS Post-op
arm group type: Active Comparator
description: Oral nutrition supplementation (ONS) pre-operatively and post-operatively up to being discharged from hospital
arm group label: ONS Pre-op + ONS Post-op + ONS Post-op 3 months
arm group type: Active Comparator
description: Oral nutrition supplementation (ONS) pre-operatively, post-operatively up to being discharged from hospital and an extended oral nutrition supplementation post-operatively up to 3 months
arm group label: Usual intake Pre-op + ONS Post-op
arm group type: Active Comparator
description: Follow a meal plan of 2000 kcal / day using conventional foods and oral nutrition supplementation (ONS) post-operatively up to being discharged from hospital
intervention type: Dietary Supplement
intervention name: ONS Pre-op + ONS Post-op
description: Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital.
arm group label: ONS Pre-op + ONS Post-op
intervention type: Dietary Supplement
intervention name: ONS Pre-op + ONS Post-op + ONS Post-op 3 months
description: Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months.
arm group label: ONS Pre-op + ONS Post-op + ONS Post-op 3 months
intervention type: Dietary Supplement
intervention name: Usual intake Pre-op + ONS Post-op
description: Participants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital
arm group label: Usual intake Pre-op + ONS Post-op
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Winnie SS Chee, PhD
role: Principal Investigator
affiliation: International Medical University
facility: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: International Medical University
investigator full name: Winnie Chee
investigator title: Principal Investigator
mesh term: Breast Neoplasms
sharing ipd: No