RCT of CBD for Anxiety in Advanced Breast Cancer

Anxiety Clinical Trial

Official title: Randomized, Double-blind Phase II Study of a Single Dose of Cannabidiol (CBD) for Acute Anticipatory Anxiety in Advanced Breast Cancer

Status Active, not recruiting

Clinical Trial Summary

This research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast cancer poised to undergo computed tomography (CT) or positron emission tomography (PET) to assess tumor burden.

The name of the study drug(s) are:

• Cannabidiol (CBD)

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled Phase II trial of a single dose of CBD for acute anticipatory anxiety in patients with advanced breast cancer undergoing computed tomography (CT) or positron emission tomography (PET) to assess tumor burden.

The research study investigates use of CBD to manage anxiety prior to an oncologic imaging scan. CBD is a component of the cannabis sativa (marijuana) plant and of hemp. Studies of CBD have led to its approval by the Food and Drug Administration for certain childhood seizure disorders. Researchers have also been studying the use of CBD to manage anxiety and pain.

This study is designed to learn if the drug can help reduce anxiety and can safely be given to participants with advanced breast cancer who are scheduled for a CT or PET scan.

• After screening procedures confirm participation in the research study, participants will be "randomized" into one of two study groups: one group will receive CBD, the other group will receive a placebo of flavored corn syrup.

• Randomization means that participants are put into a group by chance. Neither the participant nor the research team will choose participant group assignment.

• Participants will have a 66% chance of receiving a single dose of CBD.

• Participants will have a 33% chance of receiving a single dose of placebo.

• On the day of treatment, participants will complete questionnaires before and after receiving a single dose of CBD or placebo then undergo computed tomography (CT) scan or positron emission tomography (PET). Participants will be contacted by phone approximately a week later and interviewed about study drug consumption and the CT/PET scan experience.

This study is supported by funding from the Hans and Mavis Lopater Foundation.

Approximately 50 people are anticipated to take part in this study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved CBD to manage anxiety but it has been approved for use in children with some seizure disorders. ;

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Anxiety
• Anxiety Disorders
• Breast Neoplasms
• CBD

• NCT number: NCT04482244
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 19, 2022
• Completion date: December 18, 2024