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Cannabidiol Oil to Relieve Symptom Burden in Patients With Advanced Cancer
TAKE-HOME MESSAGE
- This phase II randomized clinical trial assessed whether pure cannabidiol (CBD) oil (without delta-9-tetrahydrocannabinol [THC]) can improve symptom burden compared with placebo in patients with advanced cancer and symptom distress, as determined using the Edmonton Symptom Assessment Scale (ESAS), receiving standard palliative care. There was no significant difference between the two groups, and ESAS scores improved over time, regardless of treatment. CBD oil had no significant effect on the quality of life, depression, or anxiety.
- These results indicate that CBD oil does not improve symptom burden in patients with advanced cancer. Importantly, this study used pure CBD oil without THC. Future studies should evaluate the efficacy of THC in the improvement of symptom burden in patients with advanced cancer.
abstract
This abstract is available on the publisher's site.
Access this abstract nowPURPOSE
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.
Additional Info
Phase IIb Randomized, Placebo-Controlled, Dose-Escalating, Double-Blind Study of Cannabidiol Oil for the Relief of Symptoms in Advanced Cancer (MedCan1-CBD)
J. Clin. Oncol 2022 Nov 21;[EPub Ahead of Print], J Hardy, R Greer, G Huggett, A Kearney, T Gurgenci, P GoodFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Many patients are using cannabis products for symptom management despite limited high-quality evidence to support its use. Cannabis is fully legal in 21 states, and many more have legalized it for medical use. However, many patients still do not have access to medical cannabis or do not want to use a delta-9-tetrahydrocannabinol (THC)–containing product. Cannabidiol (CBD)–only products are appealing to many patients as they are easy to obtain in retail stores/online, are non-psychoactive, and are perceived to be safe and effective. However, CBD can also have side effects and interact with other medications. Furthermore, there are very little data to suggest that CBD alone is helpful in patients with cancer.
The current randomized phase IIb dose-escalating placebo-controlled trial in 144 adults with advanced cancer and symptom distress receiving palliative care reports that the studied CBD oil, at presumably therapeutic doses, does not appear to mitigate cancer-related symptoms or improve quality of life. The dose of CBD was titrated to tolerance, with a median dose of 400 mg per day, higher than what most patients are using in the community. In addition, CBD has been shown to have a biphasic dose response, which this study did not consider. This study used synthetic CBD, noting that a plant-based extract may be more effective given the synergy with other compounds in the plant, including terpenes and other minor cannabinoids (entourage effect). However, the findings of this trial are consistent with what many cannabis experts have observed in the clinic — that THC is often needed to help with symptom management.
Studies have demonstrated a significant placebo effect with cannabis as well as with CBD alone. Many observational studies have suggested the benefits of CBD, THC, or the combination, including those with a “wait-list” control group. Due to the large placebo effect, randomized placebo-controlled trials are desperately needed but difficult to perform in this country due to barriers to conducting such research. President Biden just signed a new bill that loosens restrictions on research, but a Schedule I license is still required, and the process remains confusing and cumbersome. Until cannabis is rescheduled, there will likely be little progress in the US to conduct high-quality randomized controlled trials to inform providers on when and how to use cannabis. While this study by Hardy et al is interesting and does support the clinical experience of many, it is not definitive. Future studies should attempt to use a full plant CBD extract with or without THC with defined dose levels and examine the effects on individual symptoms.