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

Phase 3

• Conditions: Cancer; Pain
• Interventions: Drug: oral oxycodone; Drug: oral hydromorphone; Drug: fentanyl patch

• Registration Number: NCT02084355
• Lead Sponsor: Gyeongsang National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-07
• Last Update Submitted: 2014-03-07
• Study First Posted: 2014-03-12
• Last Update Posted: 2014-03-12
• Study Start: 2014-04
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
opioid dose escalation	oral oxycodone	Patients who are randomized to opioid dose escalation will be treated cancer pain by escalation dose of same strong opioid. * oral oxycodone : maintain oral oxycodone and titrate the dose * oral hydromorphone : maintain oral hydromorphone and titrate the dose * fentanyl patch : maintain fentanyl patch and titrate the dose
opioid dose escalation	oral hydromorphone	Patients who are randomized to opioid dose escalation will be treated cancer pain by escalation dose of same strong opioid. * oral oxycodone : maintain oral oxycodone and titrate the dose * oral hydromorphone : maintain oral hydromorphone and titrate the dose * fentanyl patch : maintain fentanyl patch and titrate the dose
opioid rotation	oral hydromorphone	Patients who are randomized to opioid rotation are treated with strong opioid other than currently used strong opioid (Reduce the dose by 25%-50% to allow for incomplete cross-tolerance between different opioids). * oral oxycodone : convert to oral hydromorphone or fentanyl patch * oral hydromorphone : convert to oral oxycodone or fentanyl patch * fentanyl patch : convert to oral oxycodone or oral hydromorphone
opioid rotation	fentanyl patch	Patients who are randomized to opioid rotation are treated with strong opioid other than currently used strong opioid (Reduce the dose by 25%-50% to allow for incomplete cross-tolerance between different opioids). * oral oxycodone : convert to oral hydromorphone or fentanyl patch * oral hydromorphone : convert to oral oxycodone or fentanyl patch * fentanyl patch : convert to oral oxycodone or oral hydromorphone
opioid dose escalation	fentanyl patch	Patients who are randomized to opioid dose escalation will be treated cancer pain by escalation dose of same strong opioid. * oral oxycodone : maintain oral oxycodone and titrate the dose * oral hydromorphone : maintain oral hydromorphone and titrate the dose * fentanyl patch : maintain fentanyl patch and titrate the dose
opioid rotation	oral oxycodone	Patients who are randomized to opioid rotation are treated with strong opioid other than currently used strong opioid (Reduce the dose by 25%-50% to allow for incomplete cross-tolerance between different opioids). * oral oxycodone : convert to oral hydromorphone or fentanyl patch * oral hydromorphone : convert to oral oxycodone or fentanyl patch * fentanyl patch : convert to oral oxycodone or oral hydromorphone

Primary Outcome Measures

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

Trial Locations

Locations (1)

Gyeongsang National University Hospital; 🇰🇷 Jinju, Gyeongsangnam-do, Korea, Republic of