<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/NCT03024515</url>
  </required_header>
  <id_info>
    <org_study_id>SYM012</org_study_id>
    <nct_id>NCT03024515</nct_id>
  </id_info>
  <brief_title>Opioids Titration Study in Advanced Cancer Patients in Hong Kong</brief_title>
  <official_title>A Pilot Randomized Open-labeled Study Comparing a Structured Titration Method of immediate-and Sustained- Release Oxycodone Versus Opioids Titration of Investigators' Choice in Advanced Cancer Patients in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      Pain is a common symptom that is experienced by patients with advanced cancer. Whilst mild&#xD;
      pain can usually be controlled with simple analgesics, more severe pain may require&#xD;
      initiation of opioid analgesics. The World Health Organization (WHO) has developed a specific&#xD;
      guideline for titration of analgesics. Known as the WHO Pain Ladder, patients who have severe&#xD;
      pain despite non-opioid and weak opioid analgesics are advised to step up to level 3 -&#xD;
      &quot;Strong Opioids&quot;. Morphine is the most common opioid strong analgesic prescribed in Hong&#xD;
      Kong. To the best of our knowledge, there is no formal opioid pain control guideline&#xD;
      developed for cancer patients in Hong Kong. The prescription practices of various physicians&#xD;
      who treat advance cancer patients, including oncologists and palliative care physicians have&#xD;
      never been audited or standardized.&#xD;
&#xD;
      Furthermore, there are inherent issues with the administration of oral morphine. Currently,&#xD;
      only one fixed concentration is available in a liquid formulation. Patients are known to have&#xD;
      difficulties in receiving the appropriate dose. Accurate measurement of the volume required&#xD;
      is extremely difficult, and many a times patients will report to have spilled the oral&#xD;
      morphine during decanting, or will report that they have not been taking adequate doses&#xD;
      because they are worried that they will decant too much into a spoon or syringe and overdose&#xD;
      themselves.&#xD;
&#xD;
      Oxycodone is a semisynthetic strong opioid analgesic, which has recently been introduced to&#xD;
      Hong Kong. It is formulated as a capsule, and again, 2 preparations (sustained-release&#xD;
      (Oxycontin) and immediate release (Oxycodone IR)) are available. Inherent advantages include&#xD;
      ease of administration; different groups have previously reported less adverse effects and&#xD;
      better treatment compliance. However, to date, there has been no prospective 'head-to-head'&#xD;
      comparison have ever been carried out comparing this with the traditional, well-accepted&#xD;
      methods.&#xD;
&#xD;
      The purpose of this study is to assess whether or not the use of Oxycontin and Oxycodone IR&#xD;
      may be superior to traditional medication choices and schedules in terms of time required for&#xD;
      onset of pain control, the side effect profile, patients' tolerability and compliance to&#xD;
      treatment. Interestingly, through this randomized open-label prospective study, we also aim&#xD;
      to capture information on current opioid prescription practices by clinicians who manage&#xD;
      patients with advanced cancers, which will be useful for us to consider the establishment of&#xD;
      territory-wide treatment guidelines at a later juncture.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2018</start_date>
  <completion_date type="Actual">December 7, 2020</completion_date>
  <primary_completion_date type="Actual">December 7, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to stabilization of pain control during titration phase</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of analgesic onset</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of breakthrough medications required during the titration phase</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life assessments using the EORTC QLQ-C15-PAL instrument</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A descriptive assessment of opioids prescription practice amongst practicing oncologists in Hong Kong</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety profile and adverse events</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive summary of the use of opioids and titration by practicing clinicians</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Pain Control</condition>
  <arm_group>
    <arm_group_label>Standard Practice Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard Practice Arm with opioids titration of physicians' choice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Structured Tritration Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Structured titration method with predefined titration steps with the use of oxycodone immediate-release and oxycodone sustained-release preparations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>opioids titration</intervention_name>
    <description>Standard Practice Arm</description>
    <arm_group_label>Standard Practice Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>predefined titration steps</intervention_name>
    <description>comprising of oxycodone immediate release (OXYNORM) and oxycodone sustained release (OXYCONTIN) in pre-defined doses and frequencies</description>
    <arm_group_label>Structured Tritration Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patient with moderate to severe cancer pain, and:&#xD;
&#xD;
          2. Opioid naïve patients, who were administrated NSAIDs or weak opioids and currently&#xD;
             with poor pain control, intend to be treated with strong opioids&#xD;
&#xD;
          3. For the patients who need long term administration of hormone or targeting therapy or&#xD;
             bisphosphonates therapy, the treatments will maintain from 3 days prior to&#xD;
             randomization to end of the study as much as possible.&#xD;
&#xD;
          4. For patients who need radiotherapy or chemotherapy, these therapies should be&#xD;
             conducted during maintaining phase and completed as assuring as possible before last&#xD;
             follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The pure neuropathic pain or unexplained pain, pain that only occurs during moving;&#xD;
             Acute pain&#xD;
&#xD;
          2. The patients who are not applicable for oral administration&#xD;
&#xD;
          3. Any disease that may lead to respiration inhibition of the subjects&#xD;
&#xD;
          4. Monoamine oxidase inhibitor (MAOI) was administrated one week before randomization;&#xD;
&#xD;
          5. There are abnormal results, with obvious clinical significance, from lab testing, such&#xD;
             as the creatinine is ≥2-fold of upper limit of normal value, or ALT or AST is ≥2-fold&#xD;
             of upper limit of normal value, or liver function is Child C grade;&#xD;
&#xD;
          6. There are potential gastrointestinal diseases or the risk of surgical operation, which&#xD;
             may lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction;&#xD;
&#xD;
          7. Patients have been exposed to prolonged-release oxycodone tablets or other strong&#xD;
             opioids drugs before study.&#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>Department of Clinical Oncology, Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>CCTU</investigator_full_name>
    <investigator_title>Assistant Professor (Clinical)</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_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/NCT03024515
org study id: SYM012
nct id: NCT03024515
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pain is a common symptom that is experienced by patients with advanced cancer. Whilst mild
      pain can usually be controlled with simple analgesics, more severe pain may require
      initiation of opioid analgesics. The World Health Organization (WHO) has developed a specific
      guideline for titration of analgesics. Known as the WHO Pain Ladder, patients who have severe
      pain despite non-opioid and weak opioid analgesics are advised to step up to level 3 -
      "Strong Opioids". Morphine is the most common opioid strong analgesic prescribed in Hong
      Kong. To the best of our knowledge, there is no formal opioid pain control guideline
      developed for cancer patients in Hong Kong. The prescription practices of various physicians
      who treat advance cancer patients, including oncologists and palliative care physicians have
      never been audited or standardized.

      Furthermore, there are inherent issues with the administration of oral morphine. Currently,
      only one fixed concentration is available in a liquid formulation. Patients are known to have
      difficulties in receiving the appropriate dose. Accurate measurement of the volume required
      is extremely difficult, and many a times patients will report to have spilled the oral
      morphine during decanting, or will report that they have not been taking adequate doses
      because they are worried that they will decant too much into a spoon or syringe and overdose
      themselves.

      Oxycodone is a semisynthetic strong opioid analgesic, which has recently been introduced to
      Hong Kong. It is formulated as a capsule, and again, 2 preparations (sustained-release
      (Oxycontin) and immediate release (Oxycodone IR)) are available. Inherent advantages include
      ease of administration; different groups have previously reported less adverse effects and
      better treatment compliance. However, to date, there has been no prospective 'head-to-head'
      comparison have ever been carried out comparing this with the traditional, well-accepted
      methods.

      The purpose of this study is to assess whether or not the use of Oxycontin and Oxycodone IR
      may be superior to traditional medication choices and schedules in terms of time required for
      onset of pain control, the side effect profile, patients' tolerability and compliance to
      treatment. Interestingly, through this randomized open-label prospective study, we also aim
      to capture information on current opioid prescription practices by clinicians who manage
      patients with advanced cancers, which will be useful for us to consider the establishment of
      territory-wide treatment guidelines at a later juncture.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to stabilization of pain control during titration phase
time frame: 1 year
measure: Time of analgesic onset
time frame: 1 year
measure: Number of breakthrough medications required during the titration phase
time frame: 1 year
measure: Quality of Life assessments using the EORTC QLQ-C15-PAL instrument
time frame: 1 year
measure: A descriptive assessment of opioids prescription practice amongst practicing oncologists in Hong Kong
time frame: 1 year
measure: Safety profile and adverse events
time frame: 1 year
measure: Descriptive summary of the use of opioids and titration by practicing clinicians
time frame: 1 year
arm group label: Standard Practice Arm
arm group type: Experimental
description: Standard Practice Arm with opioids titration of physicians' choice
arm group label: Structured Tritration Arm
arm group type: Experimental
description: Structured titration method with predefined titration steps with the use of oxycodone immediate-release and oxycodone sustained-release preparations.
intervention type: Drug
intervention name: opioids titration
description: Standard Practice Arm
arm group label: Standard Practice Arm
intervention type: Drug
intervention name: predefined titration steps
description: comprising of oxycodone immediate release (OXYNORM) and oxycodone sustained release (OXYCONTIN) in pre-defined doses and frequencies
arm group label: Structured Tritration Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: CCTU
investigator title: Assistant Professor (Clinical)
mesh term: Analgesics, Opioid
sharing ipd: No