CBD can be used safely in women with advanced breast cancer and clinical anxiety

CBD can be used safely in women with advanced breast cancer and clinical anxiety

Phase II study does not show primary endpoint success but suggests potential anxiolytic benefits with a strong safety profile

Cannabidiol (CBD) is known to have anti-anxiety effects. Its ability to reduce anxiety in women with advanced breast cancer before a scan was recently examined in a randomized clinical trial (RCT). The results were published online inJAMA network opened.

Clinical anxiety is common in 20-25% of treated cancer patients, but few medications are available to treat it. Commonly used medications such as benzodiazepines have a variety of neuropsychiatric side effects, including confusion and amnesia, and can be addictive. This has made their use in oncology difficult, as only up to 25% of adult cancer patients receive these drugs.

Some research suggests that CBD safely reduces anxiety levels without negative effects on mental or neurological health. However, few of these studies involved cancer patients, which is the rationale for the present study.

Scans to assess tumor burden are known to evoke fear of scan-related pain or discomfort, progressive disease, and the unknown, which occurs in up to 81% of patients. The greatest fear occurs before the scan and therefore this period was examined in the current study.

About the study

The study was a phase II study involving 50 women with advanced breast cancer. Everyone was clinically afraid. Most were white (86%), and 88% experienced mild to moderate clinical anxiety, with the remainder reporting severe anxiety.

They were randomized into two arms, one receiving CBD and the other placebo, before a scan to assess the tumor.

Each patient in the intervention arm (mean age 60 years) received a dose of 400 mg CBD orally compared to placebo in the control arm (mean age 57 years). Anxiety was assessed using scores on the “anxiety” component of the Visual Analog Mood Scale (VAMS) measured before and 2–4 hours after CBD ingestion.

The scores were then used to assess mood change based on the derived T-score. An AT score >20 was considered a reliable change. At >30 there were both reliable and clinically relevant changes.

The main aim of the study was to compare the change in anxiety scores within 48 hours before a cancer scan, before and after taking the drug or placebo. A secondary analysis independently assessed pre- and post-dose anxiety levels in both arms, changes in other components of the VAMS scale, and drug safety.

Comparison with previous studies

There has only been one previous study that examined the effect of CBD on anxiety in cancer patients.

This study did not focus primarily on anxiety and allowed the use of benzodiazepines during the study period. The difference in anxiety scores was determined using two scores two weeks apart. No drug-grade CBD was used.

In contrast, the current study focused specifically on anxiety caused by a specific stimulus. No other cannabinoids or benzodiazepines were allowed on the day of the study. The CBD used was of regulatory quality, so its use could be expanded quickly if results showed effectiveness and were validated.

No significant difference in anxiety

Similar anxiety levels were found in both arms before the scan. The study found no significant difference in anxiety after taking CBD orally compared to before. The mean change in the “anxiety” score was -19 and -15 in the intervention vs. placebo arm, respectively, falling below the reliability threshold.

Although the difference was numerically larger for the former, it was not significant. This may be due to the small sample size as well as the lack of difference in values ​​at baseline. Additionally, the decrease in anxiety levels was greatest among those who were most anxious at baseline.

There was only a moderate correlation of 30% between the “anxiety” scores immediately before and after ingestion. This may also have contributed to the fear not changing significantly. Had the study excluded those with mild anxiety, the effects of CBD use may have been better observed.

However, the “fear” component score 2-4 hours after CBD ingestion was numerically lower in the intervention arm at 51.5, compared to 58 in the control arm. Correlations with before and after scores in several other VAMS subscales ranged from 40% to 72%, higher than for the “anxiety” component.

No adverse reactions of more than mild severity were observed.

Conclusions

This is the first study of CBD for anxiety in a subset of oncology patients. The results suggest that anxiety was significantly lower in the intervention arm than in the placebo arm 2-4 hours after taking CBD. It also shows the safety of using CBD in women with advanced breast cancer who suffer from clinical anxiety.

This suggests that CBD actually had an anti-anxiety effect, requiring further study of its effectiveness. However, there was no significant difference in the change in pre-test anxiety levels before and after taking CBD/placebo.

“We believe these signals are sufficiently intriguing to warrant further research into CBD as a safe and potentially effective therapy for cancer-related anxiety“, say the researchers.

The attractiveness of CBD treatment for these patients and their doctors provides greater incentive to demonstrate its effectiveness, as it is otherwise safe and well tolerated even in older people. Longitudinal studies that provide both subjective and objective measures of anxiety and include only oncology patients with moderate to severe anxiety using the Patient Global Impressions Scale are recommended.

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