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

Gyeongsang National University Hospital

Status and phase: Unknown; Phase 3

Conditions: Cancer; Pain

Treatments: Drug: oral oxycodone; Drug: oral hydromorphone; Drug: fentanyl patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02084355

GNUH-2013-07-014

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

opioid rotation

Experimental group

Description:

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

Treatment:

Drug: fentanyl patch

Drug: oral oxycodone

Drug: oral hydromorphone

opioid dose escalation

Active Comparator group

Description:

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

Treatment:

Drug: fentanyl patch

Drug: oral oxycodone

Drug: oral hydromorphone