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/NCT06035510</url>
    </required_header>
    <id_info>
      <org_study_id>143/2556</org_study_id>
      <nct_id>NCT06035510</nct_id>
    </id_info>
    <brief_title>Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery</brief_title>
    <official_title>Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rajavithi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rajavithi Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Major surgeries including gynecological cancer surgery can make surgical stress that leads to&#xD;
        increased burden of postoperative complications, delayed length of hospital stay and&#xD;
        increased mortality rate. Protein is one of the essential factors that contribute to the&#xD;
        recovery of patients following surgery, as the surgical process increases protein breakdown&#xD;
        in the body. Providing patients with an adequate amount of protein helps enhance muscle&#xD;
        building, aids in muscle repair, and reduces postoperative inflammation.&#xD;
  &#xD;
        One study administered a fluid containing a combination of whey protein and carbohydrates to&#xD;
        cancer patients in preoperative and postoperative periods. The result of the study shows that&#xD;
        intervention group can reduce the length of hospital stay and postoperative complications.&#xD;
  &#xD;
        However, studies focusing on the use of only-protein supplement to improve surgical&#xD;
        complications in gynecological cancer patients are limited. This study aims to investigate&#xD;
        the administration of protein supplement before and after surgery in gynecological cancer&#xD;
        patients its contribution to the reduction of length of hospital stay and postoperative&#xD;
        complications at Rajavithi Hospital.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        During admission, Participants will be randomized by a computer program into two groups as&#xD;
        the whey protein supplement group and control group. Both groups will undergo nutritional&#xD;
        assessment on the first day of admission before surgery by the Rajavithi Subjective Global&#xD;
        Assessment tool and serum albumin level.&#xD;
  &#xD;
        The whey protein supplement group : participants will receive isolated whey protein in the&#xD;
        form of two packets of isolated whey protein powder (each packet containing 11.5 grams,&#xD;
        totaling to 23 grams) mixed with water in a 350 milliliter drinking bottle at 6.00 p.m. on&#xD;
        first day before operation. After the operation, participants will receive the same form of&#xD;
        protein supplement as before surgery at 6.00 a.m. on the first day after operation.&#xD;
  &#xD;
        The control group : participants will receive standard care, which includes fasting from food&#xD;
        after midnight on the night before surgery and other standard surgical protocols.&#xD;
  &#xD;
        After surgery, participants will be assessed based on&#xD;
  &#xD;
          1. Intraoperative outcomes, which include the duration of surgery, intraoperative blood&#xD;
             loss, and intraoperative complications.&#xD;
  &#xD;
          2. The postoperative outcomes, which include length of hospital stay, duration of stay in&#xD;
             the intensive care unit (ICU), postoperative complications, postoperative pain, time to&#xD;
             first ambulation , time to first flatus , nausea and vomiting symptoms, increased&#xD;
             requests for pain medication, fever more than 24 hours after surgery , wound infection&#xD;
             and readmission.&#xD;
  &#xD;
          3. The nutritional status outcomes, assessed through serum albumin levels before surgery&#xD;
             and on the 3rd day after surgery in both groups of participants.&#xD;
  &#xD;
          4. The side effects of whey protein supplement, in the experimental group participants,&#xD;
             which will evaluate include allergic reactions, nausea, vomiting, abdominal discomfort,&#xD;
             bloating, headache, reduced appetite, elevated creatinine levels, and increased liver&#xD;
             function levels on the 3rd day and two weeks after surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 12, 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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Length of post-operative hospital stay</measure>
      <time_frame>an average of 3 days after operation</time_frame>
      <description>Length of post-operative hospital stay after operation to discharged</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>operative time</measure>
      <time_frame>start to end of operation, an average of 3 hours</time_frame>
      <description>To compare operative time between intervention group and control group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU admission</measure>
      <time_frame>an average of 3 days after operation</time_frame>
      <description>Length of ICU admission after operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of wound infection</measure>
      <time_frame>1 and 2 week after operation</time_frame>
      <description>To compare number of wound infection after operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission</measure>
      <time_frame>1 month after operation</time_frame>
      <description>To compare readmission between intervention group and control group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of serum albumin</measure>
      <time_frame>one day before operation and 3 day after operation</time_frame>
      <description>To compare serum albumin before operation and after operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Side effect of protein supplement</measure>
      <time_frame>3 day and 2 week after operation</time_frame>
      <description>To study the side effect of protein supplement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Unit of blood transfusion</measure>
      <time_frame>start to end of operation, an average of 3 hours</time_frame>
      <description>To compare unit of blood transfusion during operation between intervention group and control group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative complication</measure>
      <time_frame>start to end of operation, an average of 3 hours</time_frame>
      <description>To compare intraoperative complication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative complication</measure>
      <time_frame>Any events occur within 14 days</time_frame>
      <description>To compare postoperative complication between intervention group and control group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of pain score</measure>
      <time_frame>up to 3 days after operation</time_frame>
      <description>To compare postoperative pain score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time of first ambulation</measure>
      <time_frame>up to 3 days after operation</time_frame>
      <description>To compare time of first ambulation after operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time of first flatus and defecation</measure>
      <time_frame>up to 3 days after operation</time_frame>
      <description>To compare time of first flatus and defecation after operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of additional pain control drug</measure>
      <time_frame>up to 3 days after operation</time_frame>
      <description>To compare Number of additional pain control drug after operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body temperature</measure>
      <time_frame>Any events occur within 14 days</time_frame>
      <description>To compare post operative fever after operation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">74</enrollment>
    <condition>Whey Protein</condition>
    <condition>Postoperative Outcomes</condition>
    <condition>Gynecological Cancer Surgery</condition>
    <arm_group>
      <arm_group_label>whey protein supplement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are given lactose-free Isolated whey protein 23 gm (containing with whey protein isolate 98.7 % ,Soya lecithin 1.3 % ) which mixed with water 350 ml at 6 p.m prior to surgery and 6.00 a.m. at first day after post surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>standard operative care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants followed standard operative care</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>whey protein supplement</intervention_name>
      <description>Participants are given Isolated whey protein supplement in evening before surgery and first day of post operation to compare with standard operative care on postoperative outcomes after gynecological cancer surgery</description>
      <arm_group_label>whey protein supplement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. A Woman who suspected or diagnosed with ovarian and endometrial Cancer&#xD;
  &#xD;
            2. A Woman who candidates for elective Surgical staging of Laparotomy operation in&#xD;
               Rajavithi hospital&#xD;
  &#xD;
            3. Aged 18-70 years old&#xD;
  &#xD;
            4. Can communicate and understand Thai language very well&#xD;
  &#xD;
            5. A woman voluntarily participated in the research&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Allergy to whey protein and protein product such as cow milk and egg&#xD;
  &#xD;
            2. A Woman who diagnosed with Hypertension, Diabetes Mellitus, Chronic Kidney Disease,&#xD;
               Heart disease and Chronic liver disease&#xD;
  &#xD;
            3. A Woman who expected difficult operation such as severe pelvic adhesion or required&#xD;
               other surgeon for co-evaluation&#xD;
  &#xD;
            4. Pregnant woman or breastfeeding&#xD;
  &#xD;
            5. A Woman who denied surgery&#xD;
  &#xD;
            6. A Woman who currently take a protein supplement&#xD;
  &#xD;
            7. A Woman who take Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Bisphosphonates,&#xD;
               Levodopa ,Tetracycline and Quinolone&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wiranchana Chitti, M.D.</last_name>
      <phone>022062900</phone>
      <phone_ext>60115</phone_ext>
      <email>wiranchanaparn@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Putsarat Insin, M.D.</last_name>
      <phone>022062900</phone>
      <phone_ext>60115</phone_ext>
      <email>mamieo3020@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rajavithi</name>
        <address>
          <city>Phaya Thai</city>
          <state>Ratchathewi</state>
          <zip>10400</zip>
          <country>Thailand</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Thailand</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Whey Protein</keyword>
    <keyword>Postoperative outcomes</keyword>
    <keyword>Gynecological Cancer Surgery</keyword>
    <!-- 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/NCT06035510
  org study id: 143/2556
  nct id: NCT06035510
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Major surgeries including gynecological cancer surgery can make surgical stress that leads to
        increased burden of postoperative complications, delayed length of hospital stay and
        increased mortality rate. Protein is one of the essential factors that contribute to the
        recovery of patients following surgery, as the surgical process increases protein breakdown
        in the body. Providing patients with an adequate amount of protein helps enhance muscle
        building, aids in muscle repair, and reduces postoperative inflammation.
  
        One study administered a fluid containing a combination of whey protein and carbohydrates to
        cancer patients in preoperative and postoperative periods. The result of the study shows that
        intervention group can reduce the length of hospital stay and postoperative complications.
  
        However, studies focusing on the use of only-protein supplement to improve surgical
        complications in gynecological cancer patients are limited. This study aims to investigate
        the administration of protein supplement before and after surgery in gynecological cancer
        patients its contribution to the reduction of length of hospital stay and postoperative
        complications at Rajavithi Hospital.
  During admission, Participants will be randomized by a computer program into two groups as
        the whey protein supplement group and control group. Both groups will undergo nutritional
        assessment on the first day of admission before surgery by the Rajavithi Subjective Global
        Assessment tool and serum albumin level.
  
        The whey protein supplement group : participants will receive isolated whey protein in the
        form of two packets of isolated whey protein powder (each packet containing 11.5 grams,
        totaling to 23 grams) mixed with water in a 350 milliliter drinking bottle at 6.00 p.m. on
        first day before operation. After the operation, participants will receive the same form of
        protein supplement as before surgery at 6.00 a.m. on the first day after operation.
  
        The control group : participants will receive standard care, which includes fasting from food
        after midnight on the night before surgery and other standard surgical protocols.
  
        After surgery, participants will be assessed based on
  
          1. Intraoperative outcomes, which include the duration of surgery, intraoperative blood
             loss, and intraoperative complications.
  
          2. The postoperative outcomes, which include length of hospital stay, duration of stay in
             the intensive care unit (ICU), postoperative complications, postoperative pain, time to
             first ambulation , time to first flatus , nausea and vomiting symptoms, increased
             requests for pain medication, fever more than 24 hours after surgery , wound infection
             and readmission.
  
          3. The nutritional status outcomes, assessed through serum albumin levels before surgery
             and on the 3rd day after surgery in both groups of participants.
  
          4. The side effects of whey protein supplement, in the experimental group participants,
             which will evaluate include allergic reactions, nausea, vomiting, abdominal discomfort,
             bloating, headache, reduced appetite, elevated creatinine levels, and increased liver
             function levels on the 3rd day and two weeks after surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Length of post-operative hospital stay
  time frame: an average of 3 days after operation
  description: Length of post-operative hospital stay after operation to discharged
  measure: operative time
  time frame: start to end of operation, an average of 3 hours
  description: To compare operative time between intervention group and control group
  measure: ICU admission
  time frame: an average of 3 days after operation
  description: Length of ICU admission after operation
  measure: number of wound infection
  time frame: 1 and 2 week after operation
  description: To compare number of wound infection after operation
  measure: Readmission
  time frame: 1 month after operation
  description: To compare readmission between intervention group and control group
  measure: Level of serum albumin
  time frame: one day before operation and 3 day after operation
  description: To compare serum albumin before operation and after operation
  measure: Side effect of protein supplement
  time frame: 3 day and 2 week after operation
  description: To study the side effect of protein supplement
  measure: Unit of blood transfusion
  time frame: start to end of operation, an average of 3 hours
  description: To compare unit of blood transfusion during operation between intervention group and control group
  measure: Intraoperative complication
  time frame: start to end of operation, an average of 3 hours
  description: To compare intraoperative complication
  measure: postoperative complication
  time frame: Any events occur within 14 days
  description: To compare postoperative complication between intervention group and control group
  measure: Level of pain score
  time frame: up to 3 days after operation
  description: To compare postoperative pain score
  measure: time of first ambulation
  time frame: up to 3 days after operation
  description: To compare time of first ambulation after operation
  measure: time of first flatus and defecation
  time frame: up to 3 days after operation
  description: To compare time of first flatus and defecation after operation
  measure: Number of additional pain control drug
  time frame: up to 3 days after operation
  description: To compare Number of additional pain control drug after operation
  measure: Body temperature
  time frame: Any events occur within 14 days
  description: To compare post operative fever after operation
  arm group label: whey protein supplement
  arm group type: Experimental
  description: Participants are given lactose-free Isolated whey protein 23 gm (containing with whey protein isolate 98.7 % ,Soya lecithin 1.3 % ) which mixed with water 350 ml at 6 p.m prior to surgery and 6.00 a.m. at first day after post surgery
  arm group label: standard operative care
  arm group type: No Intervention
  description: Participants followed standard operative care
  intervention type: Dietary Supplement
  intervention name: whey protein supplement
  description: Participants are given Isolated whey protein supplement in evening before surgery and first day of post operation to compare with standard operative care on postoperative outcomes after gynecological cancer surgery
  arm group label: whey protein supplement
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wiranchana Chitti, M.D.
  phone: 022062900
  phone ext: 60115
  email: wiranchanaparn@gmail.com
  last name: Putsarat Insin, M.D.
  phone: 022062900
  phone ext: 60115
  email: mamieo3020@gmail.com
  facility: 
  status: Recruiting
  country: Thailand
  responsible party type: Sponsor