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Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478101
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : March 13, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Cancers Drug: oxycodone fentanyl Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2006 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : February 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in pain score and treatment success

Secondary Outcome Measures :
  1. Patient satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00478101

Sponsors and Collaborators
Gachon University Gil Medical Center
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Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00478101    
Other Study ID Numbers: GMO-SC-61
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008
Keywords provided by Gachon University Gil Medical Center:
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General