An Exploratory Randomised Controlled Open-Label Study of Methadone Rotation versus Other Opioid Rotation for the Treatment of Refractory Cancer Induced Bone Pai

Phase 2

• Conditions: Refractory Cancer Induced Bone Pain; Cancer - Any cancer; Anaesthesiology - Pain management

• Registration Number: ACTRN12621000141842
• Lead Sponsor: Dr Merlina Sulistio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-11
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Age at least 18 years.
•Diagnosis of solid tumour or haematological cancer with a predicted prognosis of greater than 8 weeks.
•Diagnosis of CIBP confirmed through radiological investigations and meeting the core diagnostic criteria for CIBP as defined by The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks-American Pain Society (ACTTION-APS).
•On a strong baseline opioid pre-rotation (morphine, oxycodone or hydromorphone).
•Willing to be enrolled in a trial comparing methadone to another opioid rotation, where allocation is at random (1:1).
•greater than or equal to 4 of 10 worst pain from CIBP on 0 to 10 numeric rating scale (NRS) and/ or existing opioid results in opioid toxicity (CTCAE grade 2 or greater).
•Sufficiently proficient in English to be able to complete questionnaires and provide informed consent.

Exclusion Criteria

•Received radiotherapy in the last 30 days.
•QTc >500msec.
•History of mental health condition or impaired cognition that would prevent completion of questionnaires.
•Too unwell to participate in the study as determined by the patient’s treating physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified