JORTC-PAL16

Phase 3

Recruiting

• Conditions: europathic Cancer Pain

• Registration Number: JPRN-jRCTs051190097
• Lead Sponsor: Matsuoka Hiromichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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 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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified