Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study Protocol

Background People living with terminal or life limiting conditions such as incurable cancer often have problems with pain, vomiting and other symptoms which impact quality of life. Supportive and Palliative Care aims to improve the symptoms of people with terminal conditions, particularly towards the very end of life. There are many drugs that can be used to help with these symptoms, but often they do not work, or they cause side effects for the people taking them. “Pharmacogenomics” is a way of predicting who is more likely to have a good response to drugs, and who is more likely to get side effects, based on variation in their genes. Methods This is a prospective observational study, recruiting 50 patients aged over 18, with life limiting conditions. The study aims to understand how the introduction of multi-gene pharmacogenetic test for patients receiving palliative and supportive care might impact routine prescribing practice in an acute NHS hospital setting. It will report on the nature of prescribing patterns over a 90-day period post recruitment, looking for any variation between patients with and without the presence of actionable drug-gene interactions. It will help determine the future feasibility of incorporating pharmacogenomic testing in a palliative care population based on recruitment targets versus actual recruitment achieved. A drug-gene interaction ratio for this cohort will be reported, giving an indication of the potential scale of the use of medications relevant to pharmacogenomics used in palliative care, and the potential scope of future interventions. The study involves the collection of a single blood sample, and genetic results will not be shared with participants. Discussion This single site study aims to provide preliminary data to inform study design of clinical trials that can definitively address the question of clinical utility in this population, whilst also understanding the acceptability of researching this topic in this specific patient population. Trial registration ClinicalTrials.gov ID NCT06856122, registered 20250304