e-Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2021

An Observational Study Investigating And Auditing The Safety, Tolerability And Further Efficacy Characteristics Of A Pharmaceutical Grade Cannabis-Based Medicine Prescribed To Eligible Patients For The Management Of Cancer Related Or Non-Cancer Related Pain In General And Specialty Medical Practices Australia-Wide. (#249)

Jason Sikali 1 , Courtney Fletcher 1 , Alison Gillespie 1 , Larah Hall 1 , Jeremy Henson 1 2 , Sean Hall 1 , Medical Science Liaison Team 1 , Luis Vitetta 1 3
  1. Medlab Clinical Ltd, NSW, Australia
  2. The University of New South Wales, Faculty of Medicine Clinical School, Sydney, NSW, Australia
  3. The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, Australia

Objective: A longitudinal study [1] informed on cannabis administration in chronic pain over 12 months. Several limitations contributed to participant attrition. We posited that the high attrition rate at 12 months was due to deficits of well-defined GMP certifications for the cannabis used and gut dysbiosis due to GIT administration [2].   The aim of our study was to conduct a longitudinal study with participants seeking to administer an oro-buccal nanoparticle pharmaceutical grade cannabis-based medicine. Assessments were made of safety, tolerability and efficacy of the cannabis medicine for the management of cancer/non-cancer related pain in general/specialty medicine.

Methods: A national observational study with 2000 eligible adult participants from June 2019 would be prescribed a standardized THC/CBD medicine. Validated questionnaires assessing pain, related interference scores at baseline, demography, quality of life (QoL), pain indications and adverse events, monthly, over 12 months.

Results: Interim analysis from 792 (89%) of 892 enrolled since June 2019, provided data. At 3, 6, 12-months; 656 (83%), 243 (30.6%) and 86 (11%) were followed up, respectively. BPI scores demonstrated a trend toward pain reduction from baseline (7.8) to 3-months (6.6), 6-months (6.1) and 12-months (6.0). 74/892 participants reported SAEs with 13/74 reporting SAEs as not unrelated to the medicine. 334 withdrawals (37.4%), 260 (78%) between months 2 and 6 whilst 75 (22%) between months 7 and 12. Of the participant withdrawals, 29% were lost to follow-up, 21% due to AEs/SAEs, 20% due to inadequate pain relief, 18% other, 6% cannabis-based medicine cost prohibitive, 4% became ineligible and 2% ceased administering the cannabis-based medicine.

Conclusion: Despite significant challenges this preliminary analysis reports an attrition rate attributable to driving restrictions of long duration, prohibitive medicine costs and adverse events. Notwithstanding approximately one-third of the participants remained in the study for six months and have reported improvement in pain scores.  

  1. 1. Meng H, Page MG, Ajrawat P, et al. Patient-reported outcomes in those consuming medical cannabis: a prospective longitudinal observational study in chronic pain patients. Can J Anaesth 2021; 68: 633-44.
  2. 2. Vitetta L, Sikali JF. Comment on: Patient-reported outcomes in those consuming medical cannabis: a prospective longitudinal observational study in patients with chronic pain. Can J Anesth 2021; DOI: https://doi.org/10.1007/s12630-021-02078-z