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

Primary Purpose

Cancer, Pain

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oral oxycodone
oral hydromorphone
fentanyl patch
Sponsored by
Gyeongsang National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Significant cancer pain, at least numeric rating scale 4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gyeongsang National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

opioid rotation

opioid dose escalation

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 5, 2014
Last Updated
March 7, 2014
Sponsor
Gyeongsang National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02084355
Brief Title
Study of Opioid Rotation Versus Opioid Escalation in Patients With Moderate to Severe Cancer Pain
Official Title
Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gyeongsang National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain
Keywords
Significant cancer pain, at least numeric rating scale 4

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
opioid rotation
Arm Type
Experimental
Arm 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
Arm Title
opioid dose escalation
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
oral oxycodone
Intervention Type
Drug
Intervention Name(s)
oral hydromorphone
Intervention Type
Drug
Intervention Name(s)
fentanyl patch
Primary Outcome Measure Information:
Title
The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale
Time Frame
Eighteen months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Se-Il Go, M.D.
Phone
+82 55 750 9454
Ext
9454
Email
gose1@hanmail.net
Facility Information:
Facility Name
Gyeongsang National University Hospital
City
Jinju
State/Province
Gyeongsangnam-do
ZIP/Postal Code
660-702
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se-Il Go, M.D.
Phone
+82 55 750 9454
Ext
9454
Email
gose1@hanmail.net

12. IPD Sharing Statement

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

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