Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study
Overview
- Phase
- Phase 3
- Intervention
- oral oxycodone
- Conditions
- Cancer
- Sponsor
- Gyeongsang National University Hospital
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale
- Last Updated
- 12 years ago
Overview
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.
Investigators
Jung Hun Kang
Associate Professor
Gyeongsang National University Hospital
Eligibility Criteria
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
Arms & Interventions
opioid rotation
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
Intervention: oral oxycodone
opioid rotation
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
Intervention: oral hydromorphone
opioid rotation
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
Intervention: fentanyl patch
opioid dose escalation
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
Intervention: oral oxycodone
opioid dose escalation
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
Intervention: oral hydromorphone
opioid dose escalation
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
Intervention: fentanyl patch
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