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

March 7, 2014 updated by: Jung Hun Kang, Gyeongsang National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, Korea, Republic of, 660-702
        • Gyeongsang National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: oral oxycodone
Drug: oral hydromorphone
Drug: fentanyl patch
Active Comparator: 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
Drug: oral oxycodone
Drug: oral hydromorphone
Drug: fentanyl patch

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gyeongsang National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNUH-2013-07-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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