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

NCT02084355 | Unknown Phase 3

• 1 other identifier: GNUH-2013-07-014
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pain

Keywords

Significant cancer pain; at least numeric rating scale 4

Outcome Measures

Primary Outcomes (1)

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

  Eighteen months

Study Arms (2)

opioid rotation

EXPERIMENTAL

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; Drug: oral hydromorphone; Drug: fentanyl patch

opioid dose escalation

ACTIVE COMPARATOR

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; Drug: oral hydromorphone; Drug: fentanyl patch

Interventions

oral oxycodone DRUG

opioid dose escalation; opioid rotation

oral hydromorphone DRUG

opioid dose escalation; opioid rotation

fentanyl patch DRUG

opioid dose escalation; opioid rotation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gyeongsang National University Hospital: lead

Study Sites (1)

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 660-702, South Korea

Location

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Oxycodone; Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Se-Il Go, M.D.

CONTACT

+82 55 750 9454; gose1@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 12, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

KR (1)