A study that examines the feasibility of establishing a database that examines how genes affect opioid drug response in palliative care patients

A pilot feasibility study of establishing a clinical opioid pharmacogenomics database in palliative care

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619000591156

Acronym

OPPtiC

Enrollment

Registered

2019-04-17

Start date

2019-04-18

Completion date

2020-05-29

Last updated

2021-12-13

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

Conditions

None listed

Brief summary

Pain occurs in about 60% of people with advanced cancer. Currently, there is no method of predicting which opioid pain medication works best for each person, nor predicting who will develop side effects from which medication. This project will determine if it is feasible to collect clinical, biological and genetic data, in order to provide a personalised method of achieving optimal pain control. Who is it for? You may be eligible for this study if you are an adult with pain related to cancer. Study details All participants in this study will be seen twice in addition to their usual care – once at the enrolment into the study and once 7 days later. On 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. A blood test will also be taken during this time, which includes samples for opioid levels in the blood, markers of inflammation and genetic markers. 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.

Interventions

The target group involves patients who require an opioid switch because of adverse effects or inadequate pain relief with the current opioid, as determined by clinician. Participants will be required to have blood tests (for opioid pharmacokinetic and genomic analysis and biochemistry) and complete questionnaires relating to pain intensity and opioid adverse effects. These measures will be completed on Day 0 and Day 7. A patient medication diary will be required between Day 0 to Day 7.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Cancer diagnosis Pain related to cancer and its treatment requiring opioid therapy English speaking with sufficient reading and writing ability to complete the study questionnaires Able and willing to give written informed consent.

Exclusion criteria

Australian-modified Karnofsky performance score (AKPS) less than 40 at the beginning of the study

Outcome results