International, multi-centre, double-blind, dose increment, parallel-arm, randomised controlled of duloxetine versus pregabalin over 14 days for opioid unresponsive cancer-related neuropathic pain
JORTC-PAL16
Matsuoka Hiromichi
National Cancer Center Hospital
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
+81-335422511
hiromima@ncc.go.jp
Matsuoka Hiromichi
National Cancer Center Hospital
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
+81-3-3542-2511
hiromima@ncc.go.jp
Recruiting
Jan. 27, 2020
Feb. 07, 2020
160
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
supportive care
Inpatients and outpatients with diagnoses of cancer and neuropathic pain
Age 18 years or more
KPS 27 or AKPS 28 50 or greater
Able to complete study assessments and complying with the study procedures
Ability to provide informed written consent
Pain related to cancer with a worst pain score of 4 or greater on BPI item 3 (worst pain intensity) score in the past 24 hours
Neuropathic Pain on LANSS or S-LANSS 12 or greater
An adequate opioid medication which is defined as titration to the maximum tolerated dose or titration to at least a dose of 60mg/day oral morphine equivalent dose for 24 hours unless otherwise contra-indicated
Stable regular analgesics (opioids, paracetamol, non-steroidal anti-inflammatory drugs) and any type of regular adjuvant analgesics (e.g. antidepressants, anticonvulsants, antiarrhythmic agents, N-methyl-D-aspartate receptor antagonists, and steroids) as an analgesic in the 72 hours before commencing the study.
Chemotherapy-Induced Peripheral Neuropathy (glove and stocking)
Spinal cord compression
Contraindication for duloxetine or pregabalin
Taking gabapentinoid or duloxetine for any reason within 14 days of enrollment, including the date of enrollment. (Cases of oral medication taken on the same day of the week two weeks prior may be registered)
At risk for suicide. (at the discretion of the attending physician)
Participants who have participated in a clinical study of a new chemical entity within the four weeks prior to study entry
Patients with clinically significant cognitive impairment (clinician defined) causing unreliable completion of study procedures
Patients who have a recent history of drug misuse.
Patients who are pregnant, breastfeeding or may possibly be pregnant
Other patients who are determined to be inappropriate for participation in the study by the clinical investigator.
New chemotherapy started within 14 days of baseline (Hormone, Bisphosphonate, and
Long term immunotherapy, and Targetted biological agents will be permitted)
A new chemotherapy has been started within 14 days of baseline (Hormone, Bisphosphonate, and
Long term immunotherapy, and Targetted biological agents will be permitted)
Patients with renal failure defined as eGFR 30ml/min/1.73m2 calculated according to GFR-EPI equation
Patients with severe hepatic dysfunction (total bilirubin > 2.25 mg/dL)
18age old over
No limit
Both
Neuropathic Cancer Pain
Duloxetine Arm
Pregabalin Arm
Primary outcome is to compare the worst pain intensity (BPI item 3) at Day 14.
The average pain intensity (BPI items 5) at Day 14 and 21
The worst pain intensity (BPI items 3) at Day 21
The short-form McGill Pain Questionnaire 2 (SF-MPQ-2 scores)
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL
Percentage of participants with a reduction (BPI-I items 3) of 1 point; 2 point; >2 points; 30% and 50% pain decrease from the baseline on Day3, 7 and Day14
Percentage of participants in whom increase to the maximum dose is achieved
Percentage of participants in whom can achieve personal pain goal
Percentage of participants in whom need to adjust baseline opioids and adjuvant analgesics
The completion rate of the study medication and procedures
Total daily dose of adjuvant analgesics use(on each day)
Prospectively sought adverse events with the likelihood of relationship to intervention (Toxicity)
Health service utilization-planned and unplanned contact, investigations, hospitalisations
AMED
Not applicable
Grant-in-Aid for Scientific Research (C)
Not applicable
Osaka Metropolitan University Hospital Certified Review Board
