An Exploratory Randomised Controlled Open-Label Study of Methadone Rotation versus Other Opioid Rotation for the Treatment of Refractory Cancer Induced Bone Pain
Dr Merlina Sulistio
50 participants
Feb 15, 2021
Interventional
Conditions
Summary
This trial is investigating the impact of methadone rotation for management of cancer induced bone pain (CIBP), in comparison with other opioid rotation. Who is it for? You may be eligible for this study if you are aged at least 18 years old, have a diagnosis of solid tumour or haematological cancer with a predicted prognosis of greater than 8 weeks, have a diagnosis of CIBP and are currently taking a strong opioid (morphine, oxycodone or hydromorphone). Study details Participants will be randomly allocated (by chance) to one of two arms: Arm A: Methadone rotation for 14 days Arm B: Rotation to another strong opioid (morphine, oxycodone or hydromorphone) for 14 days All participants will be asked to complete questionnaires throughout the study assessing their pain levels. Information from this study will help investigators examine the efficacy and tolerability of methadone for providing pain relief to those with CIBP.
Eligibility
Inclusion Criteria7
- 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 Criteria4
- 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.
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Interventions
Participants will be admitted to hospital and rotated from usual opioid to racemic methadone, with the initial dose administered orally or subcutaneously, in the event when the oral route is not available. The methadone dose is not prespecified and will be determined by the patients baseline opioid dose and calculated according to the European Association for Palliative Care and the European Society for Medical Oncology opioid conversion guidelines. The total daily methadone dose will be administered in three or four divided doses for the first 48 hours, with the aim of achieving a twice to three times daily dosing after 5 days. This maintenance dosing scheduled will be ongoing for the duration of the study. Adherence to the intervention will be monitored daily through review of inpatient medication records
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12621000141842