Study of Opioid Rotation Versus Opioid Escalation in Patients With Moderate to Severe Cancer Pain

Phase 3UnknownNCT02084355

Gyeongsang National University Hospital136 enrolled

Overview

Although opioid rotation is well known treatment modality in reducing pain and opioid-induced neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid escalation is more effective in controlling significant pain in cancer patients under opioid medication. \- The purpose of this study is to determine effective therapy out of opioid rotation and opioid dose escalation in patients with moderate to severe cancer pain who have been already treated with strong opioid.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

136

Conditions

Cancer Pain

Interventions

oral oxycodoneDRUG

oral hydromorphoneDRUG

fentanyl patchDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \> 18 years * patients who are being treated with one of strong opioids including oral oxycodone, oral hydromorphone, or fentanyl patch with range from 60 mg to 200 mg of oral morphine equivalent daily dose (MEDD) * moderate to severe cancer pain (numeric rating scale more than 3) at screening * patients without uncontrolled adverse effects associated with currently applied opioid Exclusion Criteria: * previous opioid rotation * unable to take oral medication * life expectancy less than a month * newly started chemotherapy and/or radiotherapy within past 2 weeks of screening * serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase \> 2.5 times of upper normal limit * serum total bilirubin or creatinine \> 1.5 times of upper normal limit

Locations (1)

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

Outcomes

Primary Outcomes

The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale

Time frame: Eighteen months

Central Contacts

Se-Il Go, M.D.

CONTACT

+82 55 750 9454 gose1@hanmail.net

Data from ClinicalTrials.gov

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