Not Yet RecruitingPhase 4ACTRN12609001071213

A Case Series Investigating the efficacy of Rotation to Methadone in Palliative Patients with Cancer Related Pain

A Case Series Investigating change in self-rated pain following Rotation to Methadone in Palliative Patients with Cancer Related Pain


Sponsor

Brisbane South Palliative Care Collaborative

Enrollment

20 participants

Start Date

Dec 17, 2009

Study Type

Interventional

Conditions

Summary

This project has been designed to investigate the efficacy of rotation to methadone for pain control in people with cancer whose pain is uncontrolled despite substantial increases in the dose of their prescribed narcotic. By uncontrolled we mean that the person has rated their pain as being equal to or above 4 on an 11 point pain rating scale that ranges from 0 (equivalent to no pain at all), to 10 (equivalent to unbearable pain). To be eligible for this study, a person’s pain must have been clinically assessed to have two different components. One component relates to the type of pain that results when injured body tissues cause pain receptors to fire (known as nociceptive pain) and the other component relates to the type of pain that results when nervous tissues is damaged (known as neuropathic pain). People who meet these conditions will be rotated to a dose of methadone that is equivalent to their previous narcotic does in terms of analgesic potential. They will be required to maintain a daily diary about their pain levels, possible narcotic side effects (such as constipation), quality of life and mood. Diary entries before rotation to methadone will be compared statistically to diary entries after rotation to methadone. If people are improved with rotation to methadone then they can keep taking it.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at whether switching to the pain medication methadone can help cancer patients aged 18 and older who have nerve-related pain that is not well controlled by their current medications. Participants must be willing to be admitted to hospital for the medication switch and must be able to give informed consent in English.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

There are 3 phases to this case series intervention. During Phase 1 all patients will have their baseline narcotic increased by at least 30% with actual dose being determined by the treating physician

There are 3 phases to this case series intervention. During Phase 1 all patients will have their baseline narcotic increased by at least 30% with actual dose being determined by the treating physician. After 3-5 days if pain levels persist above 4 on a Numeric Rating Scale (NRS) with values ranging from 0 (none) to 10 (unbearable) or the patient reports unacceptable narcotic side-effects and the patient is in agreement they will be admitted to a specialist palliative care unit (if not already an inpatient). Phase 2 involves the patient having their current narcotic ceased and an equianalgesic dose of methadone(physeptone) commenced. Patients will be ordered appropriate breakthrough medications during this time. Patients will be monitored for emergent signs of central nervous system toxicity including respiratory depression while doses of methadone are titrated until the patient is stabilized with pain scores less than 4 on the NRS. Phase 3 involves the patient being discharged home and monitored for a further 4 days. If people are improved with rotation to methadone then they can keep taking it. Throughout the study period patients will be asked to keep a daily diary. The primary outcome variable is change in rated pain from pre to post methadone rotation. The secondary outcome variables include subjective ratings of nausea and vomiting, cognitive impairment (drowsiness and unclear thinking), constipation, mood and quality of life. These changes will be assessed in the same way as subjective pain. Duration is approximately 2 to 3 weeks


Locations(1)

Australia

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ACTRN12609001071213