<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/NCT02238886</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2011-114</org_study_id>
    <nct_id>NCT02238886</nct_id>
  </id_info>
  <brief_title>Radical Cystectomy, Nutrition and Convalescence</brief_title>
  <official_title>RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a goal directed nutritional intervention&#xD;
      can reduce the convalescence period for patients undergoing radical cystectomy (RC).&#xD;
&#xD;
      The aim is to examine the effect on quality of life of a standard nutritional strategy of&#xD;
      resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery&#xD;
      versus a goal-directed nutritional intervention combining oral intake and parenteral&#xD;
      nutrition, in patients undergoing RC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized controlled trial. Inclusion criteria: Bladder cancer, ability to&#xD;
      give an informed consent. Exclusion criteria: Previous radiation therapy at the pelvic area,&#xD;
      ureterocutaneostomy or robot-assisted surgery. The intervention aims to secure that 75% of&#xD;
      the patient's total energy and protein needs are met during hospitalization.&#xD;
&#xD;
      Primary outcome: Quality of Life, using the EORTC QLQ-C30 and BLM30 questionnaire. Secondary&#xD;
      outcomes: Body-weight, Hand Grip strength, biochemical measures, length of hospital stay,&#xD;
      time to bowel recovery. The follow-up period is 12 weeks. Statistical analysis is performed&#xD;
      in collaboration with a statistician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire)</measure>
    <time_frame>meassured pre-operatively + 6 and 12 weeks following surgery</time_frame>
    <description>Change from baseline HRQoL at 6 and 12 weeks following surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>preoperatively, 6 and 12 weeks postop</time_frame>
    <description>Change from baseline weight at 6 and 12 weeks following the date of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hand grip strength</measure>
    <time_frame>pre-operatively, 6 days and 6 weeks postop</time_frame>
    <description>Change from baseline hand grip strength at 6 days and 6 weeks following the date of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>12 week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to bowel recovery</measure>
    <time_frame>12 week follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Urinary Bladder Neoplasms</condition>
  <condition>Cystectomy</condition>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Parenteral nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receives a goal-directed nutritional intervention combining oral intake and parenteral nutrition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients receives a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi</intervention_name>
    <arm_group_label>Parenteral nutrition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bladder cancer&#xD;
&#xD;
          -  Ability to give an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous radiation therapy at the pelvic area&#xD;
&#xD;
          -  Ureterocutaneostomy&#xD;
&#xD;
          -  Robot-assisted surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Line Noes Lydom</investigator_full_name>
    <investigator_title>Clinical nurse specialist</investigator_title>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Enteral nutrition</keyword>
  <keyword>Nutrition Therapy</keyword>
  <keyword>Parenteral nutrition, total</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Convalescence</mesh_term>
  </condition_browse>
  <!-- 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/NCT02238886
org study id: H-2-2011-114
nct id: NCT02238886
lead sponsor: 
The purpose of this study is to determine whether a goal directed nutritional intervention
      can reduce the convalescence period for patients undergoing radical cystectomy (RC).

      The aim is to examine the effect on quality of life of a standard nutritional strategy of
      resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery
      versus a goal-directed nutritional intervention combining oral intake and parenteral
      nutrition, in patients undergoing RC.
The study is a randomized controlled trial. Inclusion criteria: Bladder cancer, ability to
      give an informed consent. Exclusion criteria: Previous radiation therapy at the pelvic area,
      ureterocutaneostomy or robot-assisted surgery. The intervention aims to secure that 75% of
      the patient's total energy and protein needs are met during hospitalization.

      Primary outcome: Quality of Life, using the EORTC QLQ-C30 and BLM30 questionnaire. Secondary
      outcomes: Body-weight, Hand Grip strength, biochemical measures, length of hospital stay,
      time to bowel recovery. The follow-up period is 12 weeks. Statistical analysis is performed
      in collaboration with a statistician.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire)
time frame: meassured pre-operatively + 6 and 12 weeks following surgery
description: Change from baseline HRQoL at 6 and 12 weeks following surgery
measure: Body weight
time frame: preoperatively, 6 and 12 weeks postop
description: Change from baseline weight at 6 and 12 weeks following the date of surgery
measure: hand grip strength
time frame: pre-operatively, 6 days and 6 weeks postop
description: Change from baseline hand grip strength at 6 days and 6 weeks following the date of surgery
measure: length of hospital stay
time frame: 12 week follow-up
measure: Time to bowel recovery
time frame: 12 week follow-up
arm group label: Parenteral nutrition
arm group type: Experimental
description: Patients receives a goal-directed nutritional intervention combining oral intake and parenteral nutrition
arm group label: Standard treatment
arm group type: No Intervention
description: patients receives a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery
intervention type: Dietary Supplement
intervention name: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi
arm group label: Parenteral nutrition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Line Noes Lydom
investigator title: Clinical nurse specialist
mesh term: Urinary Bladder Neoplasms
mesh term: Convalescence