Duloxetine and Pregabalin for Neuropathic Cancer Pai

Phase 3

Recruiting

• Conditions: Cancer; Neuropathic Cancer Pain; Anaesthesiology - Pain management; europathic Cancer Pain; Cancer - Any cancer

• Registration Number: ACTRN12620000656932
• Lead Sponsor: niversity of Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-05
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Inpatients and outpatients with diagnoses of cancer and neuropathic pain (probable or definite neuropathic pain by IASP criteria).
Age 18 years or more.
Able to complete study assessments and comply 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 within 24 hours of baseline.
Neuropathic Pain on LANSS or s-LANSS of 12 or greater within 7 days of study commencement.
Taking stable regular analgesics and any type of regular adjuvant analgesic except pregabalin and gabapentin within 48 hours before commencing on the study. Methadone dose must be stable for 72 hours before commencing on the study.

Exclusion Criteria

Chemotherapy-Induced Peripheral Neuropathy (CIPN) (glove and stocking) as the primary pain. CIPN is allowed as an additional pain if the patient has another source of neuropathic pain.
Spinal cord compression within 4 weeks of baseline. Spinal cord compression which is untreatable or treated at least 4 weeks prior and is on a stable dose of steroids is allowed.
Contraindication for duloxetine or pregabalin.
Taking duloxetine for any reason within 2 weeks of baseline.
Taking pregabalin greater than 50 mg/day for any reason (25 mg per day if the participant has an eGFR 30-50 mL/min/1.73m2) or taking gabapentin greater than 300mg/day for any reason (150mg per day if the participant has an eGFR 30-50 mL/min/1.73m2).
Taking moclobemide or fluvoxamine or venlafaxine for any reason.
Taking reversible monoamine oxidase inhibitors (MAOIs)
Participants who have participated in a clinical trial involving a new chemical entity within four weeks prior to study entry.
Patients with clinically significant cognitive impairment (clinician defined) causing unreliable completion of study procedures.
Patients who have a current or recent history of abuse of alcohol, or recent history of substance 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.
Starting a new chemotherapy regimen within 14 days of baseline .
Patients with renal failure defined as eGFR less than 30ml/min/1.73m2 calculated according to the CKD-EPI formula. For those with a Body Mass Index (BMI)=18, the PI is to individually assess the circumstances of the participant and use an alternative approach to calculate renal function and confirm the absence of renal failure.
Bilirubin greater than twice the upper limit of normal at baseline.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is a clinically meaningful difference in the worst pain intensity (BPI item 3) (score = 2 out of 10) between groups (pregabalin vs duloxetine). [ Day 14]