Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

Advanced Solid Cancers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478101
• Other study ID #: GMO-SC-61
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2007
• Last updated: March 12, 2008
• Start date: February 2006
• Est. completion date: April 2007

Study information

• Verified date: March 2008
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2006
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Advanced Solid Cancers

Intervention

Drug:
• oxycodone fentanyl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain score and treatment success
Secondary	Patient satisfaction