A recent randomized phase 2 study suggests that cannabidiol (CBD) may help alleviate scan-related anxiety among women with advanced breast cancer. While the study did not find a statistically significant primary endpoint, secondary analyses indicate that CBD could offer notable benefits over placebo.

Study Overview

The double-masked, placebo-controlled trial enrolled 50 women aged 18 years or older with advanced breast cancer and baseline clinical anxiety. Researchers randomly assigned participants to receive either 400 mg of oral CBD (n = 25) or a placebo (n = 25) within 48 hours before undergoing a tumor burden evaluation scan.

The primary endpoint of the study was the change in score on the Visual Analog Mood Scales (VAMS) "afraid" subscale. Although the CBD group showed a numeric improvement (mean change [SD], 19.1 [15.4] for CBD vs. 15 [10.9] for placebo), the difference did not reach statistical significance. However, a between-group comparison of anxiety levels two to four hours after drug ingestion revealed significantly lower VAMS "afraid" T-scores in the CBD group (mean [SD], 51.5 [12.8]) compared with the placebo group (mean [SD], 58 [11.6]; P = .02). Importantly, no grade 3 or grade 4 toxic effects were observed.

Addressing Scan-Related Anxiety

Ilana M. Braun, MD, chief of the division of adult psychosocial oncology at Dana-Farber Cancer Institute, noted that "scanxiety" is a term increasingly used to describe the anxiety surrounding cancer imaging procedures. "Several aspects of a cancer scan can be distressing," Braun said. "Patients often worry about potential tumor growth and its implications for their quality of life and longevity. Moreover, the scan serves as a persistent reminder of their cancer diagnosis."

Rationale for the Study

Manan M. Nayak, PhD, a research scientist at Dana-Farber, explained that while benzodiazepines have long been the standard treatment for cancer-related anxiety, they carry risks such as cognitive impairment, falls, and potential for abuse. "CBD, a major component of cannabis, has been suggested to have anti-anxiety properties without the adverse effects associated with benzodiazepines or delta-9-tetrahydrocannabinol (THC)," Nayak said.

Study Methodology

The study recruited women with advanced breast cancer who experienced clinical anxiety. Researchers assessed anxiety levels using the VAMS tool, which measures mood states on a spectrum from neutral to "afraid." Participants were given the study drug approximately three hours before their scan, allowing time for the CBD to reach full effect. Anxiety levels were then reassessed and compared between the two groups.

Key Findings

Braun highlighted that while both groups exhibited a significant reduction in anxiety—likely due to the placebo effect—women in the CBD group experienced greater relief than those in the placebo group, though not enough to reach statistical significance. Notably, three hours after ingestion, the CBD group exhibited significantly lower anxiety levels than the placebo group. Additionally, no major adverse effects were reported among CBD recipients.

Unexpected Results and Future Research

Nayak expressed surprise at the level of patient and provider interest in the study, especially given that it took place during the COVID-19 pandemic. "Despite the challenges, we saw high levels of engagement, including among elderly patients," he said.

Moving forward, researchers plan to conduct a larger study to further investigate the potential of CBD in managing scan-related anxiety among cancer patients. "We are eager to expand this research with a greater number of participants to determine whether CBD offers a significant advantage over placebo in alleviating cancer-related anxiety," Nayak added.

Conclusion

While this study did not conclusively prove CBD's superiority over placebo in reducing scan-related anxiety, its findings suggest promising benefits that warrant further investigation. The research underscores the need for continued exploration into cannabinoid-based therapies to support cancer patients experiencing anxiety. With more extensive studies, CBD could potentially emerge as a viable alternative to traditional pharmacological treatments for scan-related distress.