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A Study on How Genetics Affect Changing Opioid Pain Medications for Cancer Patients

A Pragmatic Registry Trial Investigating Pharmacogenomics In Opioid Switching For Cancer Pain

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000286448
Acronym
GENOS
Enrollment
250
Registered
2025-04-14
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cancer pain is a prevalent and distressing symptom, with opioids being the primary treatment. However, individual responses to opioids vary greatly, causing unpredictable pain relief and adverse effects. Approximately 30-40% of cancer patients experience "opioid failure," necessitating an "opioid switch" due to inadequate pain relief or toxicity. This study will investigate biological measures (biomarkers) to develop precision opioid prescribing for cancer patients. Who is it for? You may be eligible for this study if you are an adult who has incurable/advanced cancer with pain related to cancer and you are currently taking opioid medications to treat your cancer pain. Study details All participants in this study will be seen several times, and this may be either during or in addition to their usual care - once at the time of enrolment into the study, then at 2, 4, 6, and 8 weeks after their enrolment. Participants who are identified as candidates for opioid switching will also be seen at 72 hours before the opioid switch, at the time of the switch and again within 3-14 days after the opioid switch. On each of these days participants will be asked for clinical information and to complete some questionnaires about their symptoms (questions about pain relief, side effects and levels of function) and given questionnaires to complete regarding their symptoms and pain levels. One blood test will also be taken during this time, which includes samples for opioid levels in the blood, markers of inflammation and genetic markers. If participants undergo opioid switch, an optional additional blood test will be taken to measure opioid levels in the blood. It is hoped that this research will determine whether it is possible to provide more personalised pain relief based on a patient’s clinical, biological and genetic information. The effect of the opioid switching on pain levels up to 2 months after the medication change will also be assessed to determine whether the change has any impact on participants pain levels.

Interventions

The "switch" group involves patients who require an opioid switch. The criteria for opioid switch is if the patient experiences the following which is unable to be relieved by usual means: (1) uncontrolled pain (average pain score greater than or equal to 4/10), or (2) at least 1 uncontrolled opioid-related adverse effect (score greater than or equal to 4/10), or (3) issues with safety, such as the inability to tolerate thecurrent opioid. Reviews will be done fortnightly to determine need for op

The "switch" group involves patients who require an opioid switch. The criteria for opioid switch is if the patient experiences the following which is unable to be relieved by usual means: (1) uncontrolled pain (average pain score greater than or equal to 4/10), or (2) at least 1 uncontrolled opioid-related adverse effect (score greater than or equal to 4/10), or (3) issues with safety, such as the inability to tolerate thecurrent opioid. Reviews will be done fortnightly to determine need for opioid switching. If the patient is experiencing difficulties with their opioid in between reviews, they are able to contact the study team in between reveiws and will be assessed for suitability for opioid switching at that time. These reviews will be conducted by the palliative care trials team. When switching, patients on oxycodone will be allocated to receive morphine, whereas those on morphine will be allocated to receive oxycodone. This step may be skipped if needed for clinical safety reasons or according to clinician judgement of the safest and most effective likely treatment decision for the patient. Those requiring further opioid switch will be allocated to receiving other opioids not previously used. Participants will be required to have blood tests (for opioid pharmacokinetic and genomic analysis and biochemistry) and complete questionnaires relating to pain intensity, opioid adverse effects, mood, and quality of life. These measures will be completed at the same timepoints as the control group. Questionnaires will take up to 20 minutes to complete each time. Additionally, these measures will also be completed within 72 hours before the opioid switch and within 3-14 days after the opioid switch. There is no maximum allowed number of times that a participant may undergo opioid switch, as this will depend upon clinical need. After this 8-week active observation period, the medical record will be reveiwed for up to 52 weeks from date of enrolment to ascertain if further opioid switches occur. Opioid switching is a normal part of usual care. However, in order to fulfill the objectives of the study, this study includes only those who are on slow release oxycodone or morphine at study entry and the allocation of opioids at switching is specific to the study. The patients included in this study will form part of the registry. The registry itself is an integral part of this trial and is formed as part of the trial. Its starting date and data sources are the same as that of the trial.

Sponsors

Peter MacCallum Cancer Centre
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of incurable/advanced cancer Pain related to cancer and/or its treatment requiring opioid therapy Currently on oxycodone or morphine and taken for greater than or equal to 3 days as first regular ongoing strong slow-release opioid English speaking with sufficient reading and writing ability to complete the study questionnaires Life expectancy > 8 weeks

Exclusion criteria

Slow-release opioid used primarily for reasons other than pain (e.g., opioid replacement therapy, breathlessness)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026