A recent phase II clinical trial has explored the potential of cannabidiol (CBD) to alleviate anxiety in women with advanced breast cancer undergoing scans to assess tumor burden. Conducted by researchers at Dana-Farber Cancer Institute and Mass General Brigham, the study, published in JAMA Network Open, investigated whether a single 400 mg oral dose of CBD could reduce anxiety levels compared to a placebo.
Study Design and Patient Population
The trial involved 50 women with advanced breast cancer and clinical anxiety. Participants were randomized to receive either 400 mg of CBD or a placebo prior to a scheduled scan. Anxiety levels were measured using the Visual Analog Mood Scale (VAMS) before and 2-4 hours after ingestion of the study drug. The primary outcome was the change in anxiety scores within 48 hours before the cancer scan.
Key Findings
While the study did not meet its primary endpoint of a statistically significant difference in anxiety change scores between the CBD and placebo groups, researchers observed that anxiety levels were significantly lower 2-4 hours after CBD ingestion. Specifically, the mean change in the 'afraid' score on the VAMS was numerically greater in the CBD arm (-19) compared to the placebo arm (-15), although this difference did not reach statistical significance. However, the 'afraid' component score was numerically lower at 2-4 hours after CBD ingestion in the intervention arm, at 51.5, vs 58 in the control arm.
Notably, no adverse effects of more than mild severity were observed, highlighting the safety of CBD in this patient population.
Implications and Future Directions
"Our results lay the groundwork for larger, more definitive trials testing CBD in patients with breast cancer and other cancers as a way of reducing anxiety," said co-first author Peter Chai, MD, of the Department of Emergency Medicine at Brigham and Women's Hospital.
The findings suggest that CBD may possess anxiolytic properties in women with advanced breast cancer, warranting further investigation. Researchers emphasize the need for larger, well-controlled trials to confirm these results and explore the optimal dosing and administration of CBD for anxiety management in cancer patients. Future studies should also consider including only oncology patients with moderate to severe anxiety, as this may improve the ability to detect a significant effect of CBD.
"We believe these signals are sufficiently intriguing to justify continued exploration of CBD as a safe and possibly effective therapy for cancer-related anxiety," the researchers concluded.
