Study Title: Cannabidiol for Scan-related Anxiety in Women with Advanced Breast Cancer: A Randomized Clinical Trial
Publication: JAMA Network Open
Dana-Farber Cancer Institute authors: Manan M. Nayak, PhD, Peter Chai, MD, Paul J. Catalano, ScD, William Pirl, MD, MPH, James A. Tulsky, MD, Stephanie Tung, MD, Nancy U. Lin, MD, Nicole Andrade, BA, Sabrina Johns, MPH, Clint Vaz, MBBS, Melissa Hughes, MSc, Ilana M. Braun, MD
Summary: Dana-Farber Cancer Institute investigators conducted a randomized, double-blind phase 2 clinical trial to determine if cannabidiol (CBD) improves cancer-related anxiety. CBD is a non-intoxicating, non-addictive component of Cannabis sativa that avoids the neuropsychiatric side-effects of both delta-9-tetrahydrocannabinol (THC) and of benzodiazepines and has been shown in pilot research outside of oncology to improve anxiety. Fifty women with advanced breast cancer and clinical anxiety were randomized to receive oral herbal, Federal Drug Administration-approved CBD versus placebo within the 48 hours prior to receiving a scan to assess their cancer burden. Patients' moods were measured before and after study drug using the Visual Analog Mood Scale (VAMS). A measure of the change in anxiety level, the VAMSafraid change score, showed a stronger reduction in anxiety in the group taking CBD compared to the group taking a placebo, but the difference between the two groups was not statistically significant. However, a comparison of the VAMS anxiety levels 3 hours after study drug consumption demonstrated that patients who took CBD reported significantly lower anxiety than those who took placebo. CBD was found to be safe, with no serious adverse side effects, in this population with medical illness and, often, advanced age.
Significance: Approximately 20 to 25% of people being treated for cancer meet the criteria for clinical anxiety, yet there have been few advances in the treatment of acute anxiety in the last half century, in oncology settings-and beyond. This trial is the first oncologic CBD study focused on anxiety. While the study did not meet its primary endpoint, the intriguing findings justify continued exploration of CBD as a safe and possibly effective therapy for cancer-related anxiety.
Funding: This study was funded by the Hans and Mavis Lopater Foundation and the Gloria Spivak Faculty Advancement Fund.
