<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/NCT04404933</url>
  </required_header>
  <id_info>
    <org_study_id>StOIC-2 Project</org_study_id>
    <nct_id>NCT04404933</nct_id>
  </id_info>
  <brief_title>Study of Opioid-Induced Constipation 2 Project</brief_title>
  <acronym>StOIC-2</acronym>
  <official_title>An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Surrey County Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyowa Hakko Kirin UK, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Surrey County Hospital 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>
      The aim of the project is to investigate OIC in a real world / diverse group of patients with&#xD;
      cancer.&#xD;
&#xD;
      The objectives of the project are to determine: a) efficacy of a treatment algorithm to&#xD;
      manage OIC; b) efficacy of conventional laxatives to manage OIC; c) efficacy of PAMORAs /&#xD;
      other interventions to manage OIC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      StOIC-2 is an observational study of routine clinical practice, and will involve four&#xD;
      assessments over a period of 28 days (3 face to face; 1 telephone). Participants for StOIC 2&#xD;
      study will be identified from StOIC 1 study (CancerTrials.gov registry reference number -&#xD;
      NCT04350112). Visit 1 for StOIC 2 study will correspond to the assessment for StOIC 1 study.&#xD;
&#xD;
      Patients will be managed according to a treatment algorithm (see below), which is based on a&#xD;
      review of the evidence (and which is the basis of the Multinational Association for&#xD;
      Supportive Care in Cancer (MASCC) guideline on the treatment of constipation in patients with&#xD;
      advanced cancer). The decision to change treatment is based on efficacy / lack of efficacy&#xD;
      (as determined by the Bowel Function Index (see below), or the development of adverse&#xD;
      effects.&#xD;
&#xD;
      Step 1: Conventional Laxatives&#xD;
&#xD;
        -  Choice of laxatives at the discretion of the clinical team&#xD;
&#xD;
        -  Combination of softener and stimulant laxative&#xD;
&#xD;
        -  Laxatives to be prescribed on a regular basis&#xD;
&#xD;
      Step 2: Peripherally acting mu opioid receptor antagonist (PAMORA)&#xD;
&#xD;
        -  Choice of PAMORA at the discretion of clinical team&#xD;
&#xD;
        -  Either oral naloxegol or subcutaneous methylnaltrexone&#xD;
&#xD;
        -  PAMORA to be prescribed on a regular basis&#xD;
&#xD;
      Step 3: PAMORA + Conventional Laxatives&#xD;
&#xD;
        -  Choice of combination at the discretion of the PI/clinical team&#xD;
&#xD;
        -  Combination to be prescribed on a regular basis&#xD;
&#xD;
      Step 4: Other options&#xD;
&#xD;
      - Choice of other option at discretion of clinical team:&#xD;
&#xD;
        -  Bowel cleansing preparations (e.g. Picolax)&#xD;
&#xD;
        -  Suppositories&#xD;
&#xD;
        -  Enemas&#xD;
&#xD;
        -  Manual evacuation&#xD;
&#xD;
        -  Other drugs (e.g. lubiprostone, prucalopride)&#xD;
&#xD;
      The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer&#xD;
      diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug,&#xD;
      formulation, dose (every visit); e) Eastern Cooperative Oncology Group performance status.&#xD;
&#xD;
      The participants will also be asked to complete;&#xD;
&#xD;
        1. Bowel Function Index (BFI) - every visit. The BFI is a validated, 3 item, patient&#xD;
           reported tool for assessing the treatment of OIC. A BFI score of &gt; 30 indicates&#xD;
           suboptimally treated OIC.&#xD;
&#xD;
        2. Patient Assessment of Constipation - Quality of Life Questionnaire (PAC-QOL) - first and&#xD;
           last visit. The PAC-QOL is a validated, 28 item, patient reported tool for assessing the&#xD;
           impact of constipation over time.&#xD;
&#xD;
        3. Memorial Symptom Assessment Scale - Short Form (MSAS-SF) - first and last visit. The&#xD;
           MSAS-SF is a validated, 32 item, patient reported tool for assessing physical and&#xD;
           psychological symptoms in cancer patients.&#xD;
&#xD;
      Data will also be collected on adverse effects from medication / interventions, and reasons&#xD;
      for withdrawal from the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Resolution of OIC</measure>
    <time_frame>28 days</time_frame>
    <description>BFI &lt; 30</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in BFI</measure>
    <time_frame>28 days</time_frame>
    <description>BFI improved by 12</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Opioid-induced Constipation</condition>
  <condition>Cancer</condition>
  <condition>Cancer Pain</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment algorithm for OIC</intervention_name>
    <description>Treatment Algorithm for OIC</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants may be inpatients, outpatients, day centre patients and home care patients at&#xD;
        the sites conducting the research&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  As per StOIC 1: age &gt; 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of&#xD;
             regular opioids for at least one week&#xD;
&#xD;
          -  Diagnosis of OIC as defined by the Rome IV criteria (Lacy et al, 2016)&#xD;
&#xD;
          -  Diagnosis of inadequately treated OIC as defined by BFI &gt; 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  As per StOIC 1: inability to give informed consent; inability yo complete&#xD;
             questionnaire&#xD;
&#xD;
          -  Prognosis &gt; 1 month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Davies, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Palliative Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <zip>TR1 3LQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brighton &amp; Sussex University Hospitals</name>
      <address>
        <city>Brighton</city>
        <state>East Sussex</state>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leckhampton Court Hospice</name>
      <address>
        <city>Cheltenham</city>
        <state>Gloucestershire</state>
        <zip>GL53 0QJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospice of St. Francis</name>
      <address>
        <city>Berkhamstead</city>
        <state>Hertfordshire</state>
        <zip>HP43GW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart of Kent Hospice</name>
      <address>
        <city>Maidstone</city>
        <state>Kent</state>
        <zip>ME20 7PU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wisdom Hospice</name>
      <address>
        <city>Rochester</city>
        <state>Kent</state>
        <zip>ME1 2NU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Raphael's Hospice</name>
      <address>
        <city>Cheam</city>
        <state>London</state>
        <zip>SM3 9DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Margaret's Hospice</name>
      <address>
        <city>Yeovil</city>
        <state>Somerset</state>
        <zip>BA20 2HU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Giles Hospice</name>
      <address>
        <city>Lichfield</city>
        <state>Staffordshire</state>
        <zip>WS14 9LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham St. Mary's Hospice</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B29 7DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Catherine's Hospice</name>
      <address>
        <city>Crawley</city>
        <state>West Sussex</state>
        <zip>RH10 6BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Gemma's Hospice</name>
      <address>
        <city>Leeds</city>
        <state>Yorkshire</state>
        <zip>LS17 6QD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wheatfields Hospice</name>
      <address>
        <city>Leeds</city>
        <state>Yorkshire</state>
        <zip>LS6 2AE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospice</name>
      <address>
        <city>Sheffield</city>
        <state>Yorkshire</state>
        <zip>S11 9NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Davies A, Leach C, Caponero R, Dickman A, Fuchs D, Paice J, Emmanuel A. MASCC recommendations on the management of constipation in patients with advanced cancer. Support Care Cancer. 2020 Jan;28(1):23-33. doi: 10.1007/s00520-019-05016-4. Epub 2019 Aug 9.</citation>
    <PMID>31396746</PMID>
  </results_reference>
  <results_reference>
    <citation>Rentz AM, Yu R, Muller-Lissner S, Leyendecker P. Validation of the Bowel Function Index to detect clinically meaningful changes in opioid-induced constipation. J Med Econ. 2009;12(4):371-83. doi: 10.3111/13696990903430481.</citation>
    <PMID>19912069</PMID>
  </results_reference>
  <results_reference>
    <citation>Argoff CE, Brennan MJ, Camilleri M, Davies A, Fudin J, Galluzzi KE, Gudin J, Lembo A, Stanos SP, Webster LR. Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation. Pain Med. 2015 Dec;16(12):2324-37. doi: 10.1111/pme.12937. Epub 2015 Nov 19.</citation>
    <PMID>26582720</PMID>
  </results_reference>
  <results_reference>
    <citation>Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.</citation>
    <PMID>16036506</PMID>
  </results_reference>
  <results_reference>
    <citation>Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.</citation>
    <PMID>10964347</PMID>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid-induced constipation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
    <mesh_term>Cancer Pain</mesh_term>
    <mesh_term>Opioid-Induced Constipation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Currently, there are no plans to make IPD available to other researchers</ipd_description>
  </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/NCT04404933
org study id: StOIC-2 Project
nct id: NCT04404933
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the project is to investigate OIC in a real world / diverse group of patients with
      cancer.

      The objectives of the project are to determine: a) efficacy of a treatment algorithm to
      manage OIC; b) efficacy of conventional laxatives to manage OIC; c) efficacy of PAMORAs /
      other interventions to manage OIC.
StOIC-2 is an observational study of routine clinical practice, and will involve four
      assessments over a period of 28 days (3 face to face; 1 telephone). Participants for StOIC 2
      study will be identified from StOIC 1 study (CancerTrials.gov registry reference number -
      NCT04350112). Visit 1 for StOIC 2 study will correspond to the assessment for StOIC 1 study.

      Patients will be managed according to a treatment algorithm (see below), which is based on a
      review of the evidence (and which is the basis of the Multinational Association for
      Supportive Care in Cancer (MASCC) guideline on the treatment of constipation in patients with
      advanced cancer). The decision to change treatment is based on efficacy / lack of efficacy
      (as determined by the Bowel Function Index (see below), or the development of adverse
      effects.

      Step 1: Conventional Laxatives

        -  Choice of laxatives at the discretion of the clinical team

        -  Combination of softener and stimulant laxative

        -  Laxatives to be prescribed on a regular basis

      Step 2: Peripherally acting mu opioid receptor antagonist (PAMORA)

        -  Choice of PAMORA at the discretion of clinical team

        -  Either oral naloxegol or subcutaneous methylnaltrexone

        -  PAMORA to be prescribed on a regular basis

      Step 3: PAMORA + Conventional Laxatives

        -  Choice of combination at the discretion of the PI/clinical team

        -  Combination to be prescribed on a regular basis

      Step 4: Other options

      - Choice of other option at discretion of clinical team:

        -  Bowel cleansing preparations (e.g. Picolax)

        -  Suppositories

        -  Enemas

        -  Manual evacuation

        -  Other drugs (e.g. lubiprostone, prucalopride)

      The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer
      diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug,
      formulation, dose (every visit); e) Eastern Cooperative Oncology Group performance status.

      The participants will also be asked to complete;

        1. Bowel Function Index (BFI) - every visit. The BFI is a validated, 3 item, patient
           reported tool for assessing the treatment of OIC. A BFI score of > 30 indicates
           suboptimally treated OIC.

        2. Patient Assessment of Constipation - Quality of Life Questionnaire (PAC-QOL) - first and
           last visit. The PAC-QOL is a validated, 28 item, patient reported tool for assessing the
           impact of constipation over time.

        3. Memorial Symptom Assessment Scale - Short Form (MSAS-SF) - first and last visit. The
           MSAS-SF is a validated, 32 item, patient reported tool for assessing physical and
           psychological symptoms in cancer patients.

      Data will also be collected on adverse effects from medication / interventions, and reasons
      for withdrawal from the study.
observational model: Other
time perspective: Prospective
measure: Resolution of OIC
time frame: 28 days
description: BFI < 30
measure: Improvement in BFI
time frame: 28 days
description: BFI improved by 12
intervention type: Other
intervention name: Treatment algorithm for OIC
description: Treatment Algorithm for OIC
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Davies, MD
role: Principal Investigator
affiliation: Consultant Palliative Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
citation: Davies A, Leach C, Caponero R, Dickman A, Fuchs D, Paice J, Emmanuel A. MASCC recommendations on the management of constipation in patients with advanced cancer. Support Care Cancer. 2020 Jan;28(1):23-33. doi: 10.1007/s00520-019-05016-4. Epub 2019 Aug 9.
PMID: 31396746
citation: Rentz AM, Yu R, Muller-Lissner S, Leyendecker P. Validation of the Bowel Function Index to detect clinically meaningful changes in opioid-induced constipation. J Med Econ. 2009;12(4):371-83. doi: 10.3111/13696990903430481.
PMID: 19912069
citation: Argoff CE, Brennan MJ, Camilleri M, Davies A, Fudin J, Galluzzi KE, Gudin J, Lembo A, Stanos SP, Webster LR. Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation. Pain Med. 2015 Dec;16(12):2324-37. doi: 10.1111/pme.12937. Epub 2015 Nov 19.
PMID: 26582720
citation: Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
PMID: 16036506
citation: Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.
PMID: 10964347
responsible party type: Sponsor
mesh term: Constipation
mesh term: Cancer Pain
mesh term: Opioid-Induced Constipation
sharing ipd: No
ipd description: Currently, there are no plans to make IPD available to other researchers