BackgroundDespite improvements in medical care, patients with advanced cancer still experience substantial symptom distress. There is increasing interest in the use of medicinal cannabinoids, but there is little high quality evidence to guide clinicians. This study aims to define the role of cannabidiol (CBD) in the management of symptom burden in patients with advanced cancer undergoing standard palliative care.Methods and designThis study is a multicentre, randomised, placebo controlled, two arm, parallel trial of escalating doses of oral CBD. It will compare efficacy and safety outcomes of a titrated dose of CBD (100 mg/mL formulation, dose range 50 mg to 600 mg per day) against placebo. There is a 2-week patient determined titration phase, using escalating doses of CBD or placebo to reach a dose that achieves symptom relief with tolerable side effects. This is then followed by a further 2-week assessment period on the stable dose determined in collaboration with clinicians.DiscussionA major strength of this study is that it will target symptom burden as a whole, rather than just individual symptoms, in an attempt to describe the general improvement in wellbeing previously reported by some patients in open label, non controlled trials of medicinal cannabis. Randomisation with placebo is essential because of the well-documented over reporting of benefit in uncontrolled trials and high placebo response rates in cancer pain trials. This will be the first placebo controlled clinical trial to evaluate rigorously the efficacy, safety and acceptability of CBD for symptom relief in advanced cancer patients. This study will provide the medical community with evidence to present to patients wishing to access medicinal cannabis for their cancer related symptoms.Trial registration numberALCTRN12618001220257 Registered 20/07/2018.

Background: Despite improvements in medical care, patients with advanced cancer still experience substantial symptom distress. There is increasing interest in the use of medicinal cannabinoids but little high-quality evidence to guide clinicians. This study aims to define the role of a 1:1 delta-9-tetrahydrocannabinol/cannabidiol (THC/CBD) cannabinoid preparation in the management of symptom burden in patients with advanced cancer undergoing standard palliative care. Methods and design: One hundred fifty participants will be recruited from five sites within the Queensland Palliative Care Research Group (QPCRG) and randomly assigned to an active treatment or placebo group. This study is a pragmatic multicentre, randomised, placebo-controlled, two-arm trial of escalating doses of an oral 1:1 THC/ CBD cannabinoid preparation. It will compare efficacy and safety outcomes of a titrated dose (10 mg/10 mg/mL oral solution formulation, dose range 2.5 mg/2.5 mg-30 mg/30 mg/day) against placebo. There is a 2-week patientdetermined titration phase, using escalating doses of 1:1 THC/CBD or placebo, to reach a dose that achieves symptom relief with tolerable side effects. This is then followed by a further 2-week assessment period on the stable dose determined in collaboration with clinicians. The primary objective is to assess the effect of escalating doses of a 1:1 THC/CBD cannabinoid preparation against placebo on change in total symptom score, with secondary objectives including establishing a patient-determined effective dose, the change in total physical and emotional sores, global impression of change, anxiety and depression, opioid use, quality of life and adverse effects.

Background: The highest healthcare expenditures occur towards the end of life. Costs relate to hospital admissions and investigations to diagnose, prognosticate and direct treatment.Aims: An Australian study to compare the cost of investigations in the last 72 h of life between an inpatient palliative care unit (PCU) and a tertiary hospital. Method:We retrospectively reviewed 50 adult medical and surgical patients (admitted for >72 h and who died in hospital) from the PCU and referring tertiary centre between March and July 2016. Patients in the emergency department, intensive care, medical assessment and paediatric and obstetric units were excluded. All patients had an acute resuscitation plan and were on the 'Care of the Dying' pathway.Results: Expenditure was less if palliative care were the primary caregivers, with statistically significant differences in the amount of imaging (P < 0.001) and pathology (P < 0.001) ordered. There was no difference in microbiology (P = 0.172) and histology (P~1) ordered. Total cost of investigations for PCU patients was $1340.60 (4 of 50 patients) compared with $9467.78 (29 of 50 patients) in the tertiary hospital. PCU patients had longer lengths of stay (15.54 days vs 11.06 days) but cost less per bed day ($868.32 vs $878.79 respectively).Conclusion: Inpatient PCU are less likely to order investigations and are more costeffective. A prospective study comparing an inpatient PCU and patients at a tertiary centre, with and without consult liaison palliative care input, would be worthwhile to see if outcomes remain the same and if consult liaison palliative care affects the investigative burden.