Pain ControlNCT03024515
Opioids Titration Study in Advanced Cancer Patients in Hong Kong
A study testing opioids titration and predefined titration steps in people with Pain Control, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Control
- What is being tested?
- opioids titration and predefined titration steps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Aug 2018to 7 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient with moderate to severe cancer pain, and:
- Opioid naïve patients, who were administrated NSAIDs or weak opioids and currently with poor pain control, intend to be treated with strong opioids
- For the patients who need long term administration of hormone or targeting therapy or bisphosphonates therapy, the treatments will maintain from 3 days prior to randomization to end of the study as much as possible.
- For patients who need radiotherapy or chemotherapy, these therapies should be conducted during maintaining phase and completed as assuring as possible before last follow-up.
Who cannot join
- The pure neuropathic pain or unexplained pain, pain that only occurs during moving; Acute pain
- The patients who are not applicable for oral administration
- Any disease that may lead to respiration inhibition of the subjects
- Monoamine oxidase inhibitor (MAOI) was administrated one week before randomization;
- There are abnormal results, with obvious clinical significance, from lab testing, such as the creatinine is ≥2-fold of upper limit of normal value, or ALT or AST is ≥2-fold of upper limit of normal value, or liver function is Child C grade;
- There are potential gastrointestinal diseases or the risk of surgical operation, which may lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction;
- Patients have been exposed to prolonged-release oxycodone tablets or other strong opioids drugs before study.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
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
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.
Read more
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.
- Conditions
- Pain Control
- Being tested
- opioids titration, predefined titration steps
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioids titrationDrug
Standard Practice Arm
predefined titration stepsDrug
comprising of oxycodone immediate release (OXYNORM) and oxycodone sustained release (OXYCONTIN) in pre-defined doses and frequencies
| Study group | Role | What they receive |
|---|---|---|
| Standard Practice Arm | Experimental | Standard Practice Arm with opioids titration of physicians' choice Receives: Drug: opioids titration |
| Structured Tritration Arm | Experimental | Structured titration method with predefined titration steps with the use of oxycodone immediate-release and oxycodone sustained-release preparations. Receives: Drug: predefined titration steps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to stabilization of pain control during titration phase
Measured: 1 year
Secondary outcomes (6)
Time of analgesic onset
Measured: 1 year
Number of breakthrough medications required during the titration phase
Measured: 1 year
Quality of Life assessments using the EORTC QLQ-C15-PAL instrument
Measured: 1 year
A descriptive assessment of opioids prescription practice amongst practicing oncologists in Hong Kong
Measured: 1 year
Safety profile and adverse events
Measured: 1 year
Descriptive summary of the use of opioids and titration by practicing clinicians
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start23 Aug 2018
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ControlStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024515
- Sponsor's protocol ID
- SYM012
- Status last verified
- Jul 2021
- First submitted
- 23 Nov 2016
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03024515
- Acronym / sponsor ID
- SYM012
- Conditions
- Pain Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Practice Arm | Experimental | Drug: opioids titrationStandard Practice Arm with opioids titration of physicians' choice |
| Structured Tritration Arm | Experimental | Drug: predefined titration stepsStructured titration method with predefined titration steps with the use of oxycodone immediate-release and oxycodone sustained-release preparations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient with moderate to severe cancer pain, and:
- Opioid naïve patients, who were administrated NSAIDs or weak opioids and currently with poor pain control, intend to be treated with strong opioids
- For the patients who need long term administration of hormone or targeting therapy or bisphosphonates therapy, the treatments will maintain from 3 days prior to randomization to end of the study as much as possible.
- For patients who need radiotherapy or chemotherapy, these therapies should be conducted during maintaining phase and completed as assuring as possible before last follow-up.
Key exclusion criteria (7 listed)
- The pure neuropathic pain or unexplained pain, pain that only occurs during moving; Acute pain
- The patients who are not applicable for oral administration
- Any disease that may lead to respiration inhibition of the subjects
- Monoamine oxidase inhibitor (MAOI) was administrated one week before randomization;
- There are abnormal results, with obvious clinical significance, from lab testing, such as the creatinine is ≥2-fold of upper limit of normal value, or ALT or AST is ≥2-fold of upper limit of normal value, or liver function is Child C grade;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| opioids titrationStandard Practice Arm | Drug | Standard Practice Arm |
| predefined titration stepscomprising of oxycodone immediate release (OXYNORM) and oxycodone sustained release (OXYCONTIN) in pre-defined doses and frequencies | Drug | Structured Tritration Arm |
Primary outcome
Time to stabilization of pain control during titration phase
Time frame: 1 year
6 secondary outcomes
Time of analgesic onset
Time frame: 1 year
Number of breakthrough medications required during the titration phase
Time frame: 1 year
Quality of Life assessments using the EORTC QLQ-C15-PAL instrument
Time frame: 1 year
A descriptive assessment of opioids prescription practice amongst practicing oncologists in Hong Kong
Time frame: 1 year
Safety profile and adverse events
Time frame: 1 year
Descriptive summary of the use of opioids and titration by practicing clinicians
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opioids titration and predefined titration steps in people with Pain Control, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to stabilization of pain control during titration phase (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.