<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/NCT03832803</url>
  </required_header>
  <id_info>
    <org_study_id>2113</org_study_id>
    <nct_id>NCT03832803</nct_id>
  </id_info>
  <brief_title>Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.</brief_title>
  <official_title>Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lancashire Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lancashire Teaching Hospitals NHS Foundation Trust</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>
      Radical radiotherapy to the prostate is conventionally treated with a full bladder with the&#xD;
      aim of minimising dose to the bladder and small bowel to prevent significant side effects.&#xD;
      Tolerance of the bladder filling protocol varies depending on patients' baseline urinary&#xD;
      function. It is not uncommon for some men to have &quot;accidents&quot; during treatment causing&#xD;
      understandable distress. This can also extend the treatment time and cause knock on delays in&#xD;
      the radiotherapy department.&#xD;
&#xD;
      Several United Kingdom (UK) centres report treating with an empty bladder. The investigators&#xD;
      carried out a feasibility study comparing treatment with full bladder to empty bladder to&#xD;
      ascertain if the investigators can safely change our protocol to that of an empty bladder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 patients receiving radical radiotherapy to the prostate were randomised using closed&#xD;
      envelope technique 1:1 into 2 groups. Group A followed the conventional drinking protocol at&#xD;
      our centre (200ml prior to treatment) and group B were treated with an empty bladder.&#xD;
      Baseline, end of treatment and 6 week follow up scores were prospectively collected for&#xD;
      International prostate Symptom Score(IPSS), Late Effects Normal Tissue Task Force -&#xD;
      Subjective, Objective, Management, Analytic (LENT SOMA) bowel toxicity and quality of life&#xD;
      questionnaires. The investigators also looked at bowel and bladder Dose Volume Histogram&#xD;
      (DVH) to ensure constraints were met.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">January 25, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</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>50 patients receiving radical radiotherapy to the prostate were randomised using 1:1 into 2 groups. Group A followed the conventional drinking protocol at our centre (200ml prior to treatment) and group B were treated with an empty bladder. Baseline, end of treatment and 6 week follow up scores were prospectively collected for IPSS, LENT SOMA bowel toxicity and quality of life questionnaires.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Investigator masking for randomisation purposes only. Masking not possible for intervention whilst on treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in IPSS score</measure>
    <time_frame>Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up.</time_frame>
    <description>IPSS - The International Prostate Symptom Score is a 7 question scale which assesses urinary toxicity. Each question is scored 0-5 totalling a maximum score of 35. A score of 0-7 correlates to mildly symptomatic; 8-19, moderately symptomatic; 20-35, severely symptomatic.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in LENT SOMA score</measure>
    <time_frame>Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up.</time_frame>
    <description>LENT SOMA - The Late Effects in Normal Tissues Subjective, Objective, Management and Analytic Scales. This is a questionnaire that assesses individual bowel symptoms asking initially whether or not they occur and then scoring the frequency, the higher the score, the more frequent the event. Each question has it's own range of score which is explained on the questionnaire. The scores will be compared for individual questions and there will not be any combining of scores between questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel and bladder DVH</measure>
    <time_frame>At time of radiotherapy planning scan which happens at baseline, on day of randomisation.</time_frame>
    <description>Dose to bowel and bladder is calculated and documented if it meets the optimal or mandatory constraints</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Radiotherapy Side Effect</condition>
  <arm_group>
    <arm_group_label>Empty Bladder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empty bladder prior to treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full Bladder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conventional drinking protocol - 200ml water prior to treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Empty bladder</intervention_name>
    <description>No drinking protocol.</description>
    <arm_group_label>Empty Bladder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Full bladder</intervention_name>
    <description>Followed drinking protocol</description>
    <arm_group_label>Full Bladder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prostate cancer receiving radical radiotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not nodal disease.&#xD;
&#xD;
          -  Not prostate bed radiotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Birtle</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lancashire Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lancashire Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Preston</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT03832803
org study id: 2113
nct id: NCT03832803
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Radical radiotherapy to the prostate is conventionally treated with a full bladder with the
      aim of minimising dose to the bladder and small bowel to prevent significant side effects.
      Tolerance of the bladder filling protocol varies depending on patients' baseline urinary
      function. It is not uncommon for some men to have "accidents" during treatment causing
      understandable distress. This can also extend the treatment time and cause knock on delays in
      the radiotherapy department.

      Several United Kingdom (UK) centres report treating with an empty bladder. The investigators
      carried out a feasibility study comparing treatment with full bladder to empty bladder to
      ascertain if the investigators can safely change our protocol to that of an empty bladder.
50 patients receiving radical radiotherapy to the prostate were randomised using closed
      envelope technique 1:1 into 2 groups. Group A followed the conventional drinking protocol at
      our centre (200ml prior to treatment) and group B were treated with an empty bladder.
      Baseline, end of treatment and 6 week follow up scores were prospectively collected for
      International prostate Symptom Score(IPSS), Late Effects Normal Tissue Task Force -
      Subjective, Objective, Management, Analytic (LENT SOMA) bowel toxicity and quality of life
      questionnaires. The investigators also looked at bowel and bladder Dose Volume Histogram
      (DVH) to ensure constraints were met.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 50 patients receiving radical radiotherapy to the prostate were randomised using 1:1 into 2 groups. Group A followed the conventional drinking protocol at our centre (200ml prior to treatment) and group B were treated with an empty bladder. Baseline, end of treatment and 6 week follow up scores were prospectively collected for IPSS, LENT SOMA bowel toxicity and quality of life questionnaires.
primary purpose: Other
masking: None (Open Label)
masking description: Investigator masking for randomisation purposes only. Masking not possible for intervention whilst on treatment.
measure: Change in IPSS score
time frame: Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up.
description: IPSS - The International Prostate Symptom Score is a 7 question scale which assesses urinary toxicity. Each question is scored 0-5 totalling a maximum score of 35. A score of 0-7 correlates to mildly symptomatic; 8-19, moderately symptomatic; 20-35, severely symptomatic.
measure: Change in LENT SOMA score
time frame: Baseline to end of treatment (4 weeks or 7 and a half weeks depending on radiotherapy schedule); to 6 week follow up; and to 1 year follow up.
description: LENT SOMA - The Late Effects in Normal Tissues Subjective, Objective, Management and Analytic Scales. This is a questionnaire that assesses individual bowel symptoms asking initially whether or not they occur and then scoring the frequency, the higher the score, the more frequent the event. Each question has it's own range of score which is explained on the questionnaire. The scores will be compared for individual questions and there will not be any combining of scores between questions.
measure: Bowel and bladder DVH
time frame: At time of radiotherapy planning scan which happens at baseline, on day of randomisation.
description: Dose to bowel and bladder is calculated and documented if it meets the optimal or mandatory constraints
arm group label: Empty Bladder
arm group type: Experimental
description: Empty bladder prior to treatment.
arm group label: Full Bladder
arm group type: Other
description: Conventional drinking protocol - 200ml water prior to treatment.
intervention type: Behavioral
intervention name: Empty bladder
description: No drinking protocol.
arm group label: Empty Bladder
intervention type: Behavioral
intervention name: Full bladder
description: Followed drinking protocol
arm group label: Full Bladder
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alison Birtle
role: Principal Investigator
affiliation: Lancashire Teaching Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No