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Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00478101
Enrollment
2006
Registered
2007-05-24
Start date
2006-02-28
Completion date
2007-04-30
Last updated
2008-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Cancers

Keywords

Pain

Brief 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. 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.

Interventions

DRUGoxycodone fentanyl

Sponsors

Gachon University Gil Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Change in pain score and treatment success

Secondary

MeasureTime frame
Patient satisfaction

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026