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

NCT ID: NCT02084355

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

oral oxycodone

Intervention Type: DRUG

oral hydromorphone

Intervention Type: DRUG

fentanyl patch

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

oral oxycodone

Intervention Type: DRUG

oral hydromorphone

Intervention Type: DRUG

fentanyl patch

Intervention Type: DRUG

Interventions

oral oxycodone

Intervention Type: DRUG

oral hydromorphone

Intervention Type: DRUG

fentanyl patch

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gyeongsang National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jung Hun Kang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

Countries

South Korea

Central Contacts

Se-Il Go, M.D.

Role: CONTACT

gose1@hanmail.net

+82 55 750 9454 ext. 9454

Facility Contacts

Se-Il Go, M.D.

Role: primary

gose1@hanmail.net

+82 55 750 9454 ext. 9454

Other Identifiers

GNUH-2013-07-014

Identifier Type: -

Identifier Source: org_study_id