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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study

Conditions
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Cancer, Pain

Intervention / Treatment
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* Drug: oral oxycodone
* Drug: oral hydromorphone
* Drug: fentanyl patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: opioid rotation<br>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 | Drug: oral oxycodone<br> <br> Drug: oral hydromorphone<br> <br> Drug: fentanyl patch<br> <br> |
| Active Comparator: opioid dose escalation<br>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 | Drug: oral oxycodone<br> <br> Drug: oral hydromorphone<br> <br> Drug: fentanyl patch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale |  | Eighteen months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Significant cancer pain, at least numeric rating scale 4