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Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

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ClinicalTrials.gov Identifier: NCT00478101
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : March 13, 2008
Information provided by:
Gachon University Gil Medical Center

May 22, 2007
May 24, 2007
March 13, 2008
February 2006
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Change in pain score and treatment success
Same as current
Complete list of historical versions of study NCT00478101 on ClinicalTrials.gov Archive Site
Patient satisfaction
Same as current
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Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain
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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.

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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Advanced Solid Cancers
Drug: oxycodone fentanyl
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2007
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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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Gachon University Gil Medical Center
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Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
Gachon University Gil Medical Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP