JORTC-PAL16

JRCT ID: jRCTs051190097

Registered date:27/01/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neuropathic Cancer Pain
• Date of first enrollment: 07/02/2020
• Target sample size: 160
• Countries of recruitment: Australia,Japan
• Study type: Interventional

Intervention(s)

Duloxetine Arm
Pregabalin Arm

Outcome(s)

• Primary Outcome: Primary outcome is to compare the worst pain intensity (BPI item 3) at Day 14.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 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.

Exclude criteria

Chemotherapy-Induced Peripheral Neuropathy (glove and stocking)

Spinal cord compression

Contraindication for duloxetine or pregabalin

Taking gabapentioids or duloxetine for any reason within 2 weeks.

Taking SSRI or SNRI for any reason.

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 hepatic failure (Child Pugh B or C)

Related Information

• Primary Sponsor: Matsuoka Hiromichi
• Source(s) of Monetary Support: AMED,Grant-in-Aid for Scientific Research (C)