Phase IIb Randomized, Placebo-Controlled, Dose-Escalating, Double-Blind Study of Cannabidiol Oil for the Relief of Symptoms in Advanced Cancer (MedCan1-CBD)

Author(s): Janet Hardy, MD, FRACP1,2; Ristan Greer, PhD2,3; Georgie Huggett, BN1; Alison Kearney, FRACP4,5; Taylan Gurgenci, FRACGP1,2; and Phillip Good, PhD, FRACP1,2,6
Source: DOI: 10.1200/JCO.22.01632 Journal of Clinical Oncology 41, no. 7 (March 01, 2023) 1444-1452.

Dr. Anjan Patel's Thoughts

CBD oil did not change symptom thresholds in patients, and there was no detectable effect on QOL or mood disorders.

PURPOSE

To determine whether cannabidiol (CBD) oil can improve symptom distress in patients with advanced cancer receiving palliative care.

METHODS

Participants were adults with advanced cancer and symptom distress (Edmonton Symptom Assessment Scale [ESAS] total score of ≥ 10/90) who received titrated CBD oil 100 mg/mL, 0.5 mL once daily to 2 mL three times a day, or matched placebo for 28 days. The primary outcome was ESAS total symptom distress score (TSDS) at day 14. Response was defined as a decrease in TSDS by ≥ 6 at day 14. Secondary outcomes were ESAS TSDS over time, individual symptom scores, patient-determined effective dose, opioid use, Global Impression of Change, depression, anxiety, quality of life, and adverse events.

RESULTS

Of the 144 patients randomly assigned, the planned sample size of 58 participants on CBD and 63 on placebo reached the primary analysis point (day 14). The unadjusted change in TSDS from baseline to day 14 was –6.2 (standard deviation, 14.5) for placebo and –3.0 (standard deviation, 15.2) for CBD with no significant difference between arms (P = .24). Similarly, there was no detected difference in proportion of responders (placebo: 37 of 63 [58.7%], CBD: 26 of 58 [44.8%], P = .13). All components of ESAS improved (fell) over time with no difference between arms. The median dose of participant-selected CBD was 400 mg per day with no correlation with opioid dose. There was no detectable effect of CBD on quality of life, depression, or anxiety. Adverse events did not differ significantly between arms apart from dyspnea that was more common with CBD. Most participants reported feeling better or much better at days 14 (53% CBD and 65% placebo) and 28 (70% CBD and 64% placebo).

CONCLUSION

CBD oil did not add value to the reduction in symptom distress provided by specialist palliative care alone.

Author Affiliations

1Department Palliative and Supportive Care, Mater Health Services, South Brisbane, Queensland, Australia; 2Mater Research Institute—University of Queensland, Brisbane, Queensland, Australia; 3Torus Research, Brisbane, Queensland, Australia; 4Department of Palliative and Supportive Care, Royal Brisbane and Women’s Hospital, Herston, Brisbane, Australia; 5Faculty of Medicine, University of Queensland, Herston, Queensland, Australia; 6Department of Palliative Care, St Vincent’s Private Hospital Brisbane, Brisbane, Queensland, Australia

Leave a Comment

Your email address will not be published. Required fields are marked *