Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

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.

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Key information

Conditions

Advanced Solid Cancers Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxycodone fentanyl

Drug

Primary outcomes

Change in pain score and treatment success

Secondary outcomes

Patient satisfaction

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Important dates

Study start: 2006
Study completion: 2007
First posted: May 24, 2007
Registry last updated: Mar 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed