The following is a summary of “Phase IIb Randomized, Placebo-Controlled, Dose-Escalating, Double-Blind Study of Cannabidiol Oil for the Relief of Symptoms in Advanced Cancer (MedCan1-CBD),” published in the March 2023 issue of Oncology by Hardy, et al.

For a study, researchers sought to investigate whether cannabidiol (CBD) oil can alleviate symptom distress in patients with advanced cancer receiving palliative care. 

The study included 144 adults with advanced cancer and symptom distress (Edmonton Symptom Assessment Scale [ESAS] total score of ≥ 10/90) who were randomized to receive 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 the ESAS total symptom distress score (TSDS) on day 14. The response was defined as a decrease in TSDS by ≥ 6 on day 14, and secondary outcomes included individual symptom scores, patient-determined effective dose, opioid use, Global Impression of Change, depression, anxiety, quality of life, and adverse events. 

Of the planned sample size of 58 participants on CBD and 63 on placebo, the primary analysis was reached for 58 CBD and 63 placebo participants. The unadjusted change in TSDS from baseline to day 14 was -6.2 (SD 14.5) for placebo and -3.0 (SD 15.2) for CBD, with no significant difference between arms (P=0.24). Similarly, there was no significant difference in the proportion of responders (placebo: 37 of 63 [58.7%], CBD: 26 of 58 [44.8%], P=0.13). All components of ESAS improved over time with no difference between arms. The median dose of participant-selected CBD was 400 mg daily 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 which was more common with CBD. Most participants reported feeling better or much better on days 14 (53% CBD and 65% placebo) and 28 (70% CBD and 64% placebo). 

In conclusion, CBD oil did not provide additional benefits in reducing symptom distress in patients with advanced cancer who were already receiving specialist palliative care.

Reference: ascopubs.org/doi/full/10.1200/JCO.22.01632