Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

Gachon University Gil Medical Center

Status and phase

Completed

Phase 2

Conditions

Advanced Solid Cancers

Treatments

Drug: oxycodone fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT00478101

GMO-SC-61

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,006 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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