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Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

Phase 2
Completed
Conditions
Advanced Solid Cancers
Registration Number
NCT00478101
Lead Sponsor
Gachon University Gil Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2006
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in pain score and treatment success
Secondary Outcome Measures
NameTimeMethod
Patient satisfaction
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