Medicinal cannabis for symptom control in advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of 1:1 tetrahydrocannabinol and cannabidiol
Janet R Hardy 1, Ristan M Greer 2 3, Anita M Pelecanos 4 5, Georgie E Huggett 2 6, Alison M Kearney 7 8, Taylan H Gurgenci 2 6, Phillip D Good 2 6 9
- 1Mater Research Institute, University of Queensland, Aubigny Place, Mater Health SEQ, Brisbane, QLD, 4101, Australia. Janet.Hardy@mater.uq.edu.au.
- 2Mater Research Institute, University of Queensland, Aubigny Place, Mater Health SEQ, Brisbane, QLD, 4101, Australia.
- 3Torus Research, Brisbane, Australia.
- 4Statistics Unit, QIMR Berghofer Medical Research Institute, Herston, Brisbane, Australia.
- 5School of Nursing, Midwifery and Social Work, University of Queensland, Brisbane, Australia.
- 6Department of Palliative and Supportive Care, Mater Misericordiae Ltd, South East Queensland, Brisbane, Australia.
- 7Department of Palliative and Supportive Care Service, Royal Brisbane and Women’s Hospital, Herston, Brisbane, QLD, Australia.
- 8Faculty of Medicine, The University of Queensland, Herston, Brisbane, QLD, Australia.
- 9Department of Palliative Care, St Vincent’s Private Hospital Brisbane, Brisbane, QLD, Australia.
Affiliationer
Purpose: Patients with cancer commonly access cannabis hoping to relieve their symptoms. This study assessed whether a 1:1 10 mg/ml THC:CBD combination oil could improve total symptom burden in patients with advanced cancer over that provided by palliative care alone.
Methods: Participants were randomised to medicinal cannabis (MC) or placebo oil; dose escalated over 14 days according to tolerance and efficacy and continued to day 28. Symptoms assessed using the Edmonton Symptom Assessment Scale (ESAS) were summated to give a total symptom distress score (TSDS). The primary outcome measure was the change from baseline in TSDS at day 14. Secondary outcomes included individual symptom scores, opioid use, participant-selected dose, QoL, psychological symptoms, global impression of change (GIC), and adverse effects.
Results: The pre-planned sample size of 120 at day 14 was reached following the randomisation of 144 patients. Mean (SD) TSDS improved over time in both arms (- 6.30 (12.3) MC, – 6.98 (12.56) placebo, p = 0.76) to day 14 with no difference between arms. A statistically significant improvement in ESAS pain scores in the MC arm (mean (SD) – 1.42 (2.15) MC and – 0.46 (2.83) placebo, p = 0.04) was at the expense of greater psychomimetic toxicity. Improvement in general well-being was greater for the placebo. GIC and the pain component of QoL both favoured MC.
Conclusions: Patients can be informed that a 1:1 THC:CBD combination cannabis oil was no better than palliative care alone in palliating symptoms in patients with advanced cancer. A small benefit in pain control was associated with greater toxicity.
