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Opioid Rotation Versus Combin...

Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain

Last Updated: 2008-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2006 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Solid Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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oxycodone fentanyl

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers