Advanced Solid CancersPhase 2NCT00478101
Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain
A Phase 2 study testing oxycodone fentanyl in people with Advanced Solid Cancers, run by Gachon University Gil Medical Center.
Trial summary
For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Solid Cancers
- What is being tested?
- oxycodone fentanyl
- How many people
- 2,006 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Apr 2007
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Uncontrolled Pain That Required Stronger Opioid Therapy Than They Have Been Taking
- Histologically Confirmed Solid Cancer
- Aged Over 18 Years
- Admitted in a Palliative Cancer Care Unit
Who cannot join
- Uspected to Have Narcotic Abuse, Clinically Relevant CO2 Retention or Had an Active Skin Disease
- Inability to swallow oral medication, and impaired sensory or cognitive function
- Patients who had an active infection, uncontrolled central nervous system involvement, or on antitumor therapy of any kind
About this study
For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons.
The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl.
Read the detailed description
Patients with uncontrolled cancer pain despite treatment of oral morphine equivalent ≥100 mg/d will be randomly assigned to oral opioids to transdermal fentanyl (rotation group) or oral oxycodone plus fentanyl (combination group). Patients answer a questionnaire that included pain severity (0 to 10) and interference items at baseline and after one week. Primary outcomes are change in pain score and treatment success.
- Conditions
- Advanced Solid Cancers
- Being tested
- oxycodone fentanyl
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxycodone fentanylDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score and treatment success
Secondary outcomes (1)
Patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startFeb 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid CancersStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Se Hoon Park, MD, Principal investigator, Gachon University Gil Medical Center, Incheon, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478101
- Sponsor's protocol ID
- GMO-SC-61
- Status last verified
- Mar 2008
- First submitted
- 22 May 2007
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim HJ, Kim YS, Park SH. Opioid rotation versus combination for cancer patients with chronic uncontrolled pain: a randomized study. BMC Palliat Care. 2015 Sep 16;14:41. doi: 10.1186/s12904-015-0038-7.
PubMed 26377913
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain
- ClinicalTrials.gov ID
- NCT00478101
- Acronym / sponsor ID
- GMO-SC-61
- Conditions
- Advanced Solid Cancers
- Keywords
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,006 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 24 May 2007 (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.
For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons.
The present study isdesigned to assess the analgesic profiles of two different strategies in chronic cancer pain: the opioid rotation from oxycodone to transdermal fentanyl and the combination of oral oxycodone and transdermal fentanyl.
Detailed description
Patients with uncontrolled cancer pain despite treatment of oral morphine equivalent ≥100 mg/d will be randomly assigned to oral opioids to transdermal fentanyl (rotation group) or oral oxycodone plus fentanyl (combination group). Patients answer a questionnaire that included pain severity (0 to 10) and interference items at baseline and after one week. Primary outcomes are change in pain score and treatment success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic Uncontrolled Pain That Required Stronger Opioid Therapy Than They Have Been Taking
- Histologically Confirmed Solid Cancer
- Aged Over 18 Years
- Admitted in a Palliative Cancer Care Unit
Key exclusion criteria (3 listed)
- Uspected to Have Narcotic Abuse, Clinically Relevant CO2 Retention or Had an Active Skin Disease
- Inability to swallow oral medication, and impaired sensory or cognitive function
- Patients who had an active infection, uncontrolled central nervous system involvement, or on antitumor therapy of any kind
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 |
|---|---|---|
| oxycodone fentanyl | Drug | – |
Primary outcome
Change in pain score and treatment success
1 secondary outcome
Patient satisfaction
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 13 Mar 2008.
- Derived from this study: PubMed 26377913Kim HJ, Kim YS, Park SH. Opioid rotation versus combination for cancer patients with chronic uncontrolled pain: a randomized study. BMC Palliat Care. 2015 Sep 16;14:41. doi: 10.1186/s12904-015-0038-7.
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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.
Se Hoon Park, MD principal investigator
Gachon University Gil Medical Center, Incheon, Korea
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxycodone fentanyl in people with Advanced Solid Cancers, run by Gachon University Gil Medical Center.
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 3 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 13 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in pain score and treatment success. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00478101, which also lists 1 linked publication.
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 13 Mar 2008.