Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain
Information source: Gachon University Gil Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Solid Cancers
Intervention: oxycodone fentanyl (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Gachon University Gil Medical Center Official(s) and/or principal investigator(s):
Se Hoon Park, MD, Principal Investigator, Affiliation: Gachon University Gil Medical Center, Incheon, Korea
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.
Clinical Details
Study design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Change in pain score and treatment success
Secondary outcome: Patient satisfaction
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.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: February 2006
Ending date: April 2007
Last updated: March 12, 2008
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