Neuropathic Cancer Pain
Conditions
Interventions
Duloxetine Arm
Pregabalin Arm
Sponsors
Matsuoka Hiromichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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) Taking SSRI or SNRI for any reason. Taking reversible monoamine oxidase inhibitors (MAOIs). 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is to compare the worst pain intensity (BPI item 3) at Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 The Hospital Anxiety and Depression Scale (HADS) Daily opioid dose (on each day) Toxicity assessment (NCI CTCAE; Nausea, Light-headedness, Sleepiness, Oedema/PRO CTCAE) 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 | — |
Countries
Australia, Japan
Contacts
Public ContactHiromichi Matsuoka
National Cancer Center Hospital
Outcome results
None listed