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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02084355
Recruitment Status : Unknown
Verified March 2014 by Jung Hun Kang, Gyeongsang National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
Jung Hun Kang, Gyeongsang National University Hospital

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.


Condition or disease Intervention/treatment Phase
Cancer Pain Drug: oral oxycodone Drug: oral hydromorphone Drug: fentanyl patch Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : April 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

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



Primary Outcome Measures :
  1. The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale [ Time Frame: Eighteen months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084355


Contacts
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Contact: Se-Il Go, M.D. +82 55 750 9454 ext 9454 gose1@hanmail.net

Locations
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Korea, Republic of
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, Korea, Republic of, 660-702
Contact: Se-Il Go, M.D.    +82 55 750 9454 ext 9454    gose1@hanmail.net   
Sponsors and Collaborators
Gyeongsang National University Hospital
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Responsible Party: Jung Hun Kang, Associate Professor, Gyeongsang National University Hospital
ClinicalTrials.gov Identifier: NCT02084355    
Other Study ID Numbers: GNUH-2013-07-014
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014
Keywords provided by Jung Hun Kang, Gyeongsang National University Hospital:
Significant cancer pain
at least numeric rating scale 4
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Fentanyl
Oxycodone
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics