CBD for Anxiety in Breast Cancer

Overseen By Peter R Chai, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Clobazam, Valproic acid, Antiretrovirals

Disqualifiers: Uncontrolled illness, Psychiatric illness, Hepatocellular carcinoma, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a single dose of cannabidiol (CBD) can reduce anxiety in people with advanced breast cancer before imaging scans like CT or PET. Participants will receive either CBD or a placebo at random, and questionnaires will measure their anxiety levels before and after the scans. The study seeks individuals with Stage IV or metastatic breast cancer who usually experience at least mild anxiety before such scans. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you do not use cannabis, delta-9-tetrahydrocannabinol, or cannabidiol within 24 hours before taking the study drug. You also cannot take benzodiazepines within 8 hours before the study drug. If you are currently using clobazam, valproic acid, or antiretroviral therapy, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CBD is safe for people with advanced breast cancer. Studies have found that women with this condition and anxiety tolerated CBD well. Another study found that CBD did not significantly change anxiety levels compared to a placebo, but it was safe to use. Other research noted side effects like reduced food intake and weight loss in animals given CBD. Overall, evidence suggests that CBD is generally safe for humans dealing with anxiety and cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anxiety?

Unlike standard treatments for anxiety in breast cancer patients, which often involve medications like SSRIs or benzodiazepines that can have various side effects, cannabidiol (CBD) offers a unique approach. CBD is derived from the cannabis plant and is thought to have calming effects without the psychoactive impact associated with THC, another compound from the same plant. Researchers are excited because CBD may provide anxiety relief more quickly and with fewer side effects, offering a natural alternative to traditional medications. Moreover, its potential anti-inflammatory properties could benefit overall cancer treatment by reducing inflammation-related stress.

What evidence suggests that CBD might be an effective treatment for anxiety in breast cancer?

Research has shown that cannabidiol (CBD), which participants in this trial may receive, can help manage anxiety in women with advanced breast cancer. Studies have found that CBD is safe and may lower anxiety levels in these patients within a few hours of use. Women with breast cancer have previously used CBD to reduce anxiety, especially before scans like CT or PET that check for cancer spread. Results from a clinical trial showed that CBD can be safely used by women with this type of cancer and anxiety. CBD likely works by interacting with the brain's systems that control mood and stress. Participants in this trial will receive either a single dose of CBD or a placebo before their diagnostic scans. ^{1 3 6 7 8}

Who Is on the Research Team?

Ilana M Braun, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults over 18 with advanced breast cancer and mild anxiety before oncologic scans can join. They must have good organ function, not drive for 12 hours after taking the drug, speak English, avoid cannabis products for a day before, and use contraception if needed. Excluded are those with uncontrolled illnesses or allergies to CBD or placebo ingredients.

Inclusion Criteria

My organs and bone marrow are working well.

I can care for myself but may not be able to do active work.

You feel a little bit anxious before getting a scan for cancer.

Exclusion Criteria

Participants with psychiatric illness or social situations that would limit compliance with study requirements

I do not have any uncontrolled illnesses like severe infections, heart failure, or irregular heartbeats.

I have liver cancer or hard-to-control diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of CBD or placebo and complete questionnaires before and after the dose, followed by a CT or PET scan

1 day

1 visit (in-person)

Follow-up

Participants are contacted by phone approximately a week later to discuss study drug consumption and the CT/PET scan experience

1 week

1 visit (phone call)

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol
• Placebo

Trial Overview The trial is testing whether a single dose of cannabidiol (CBD) can reduce anticipatory anxiety in patients with advanced breast cancer who are about to get CT or PET scans. Participants will randomly receive either CBD or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Cannabidiol Experimental Treatment 1 Intervention

After screening procedures confirm participation in the research study, participants will be randomized one of two groups: * Participants in the experimental arm will complete questionnaires and then receive a single dose of CBD prior to diagnostic CT scan or positron emission tomography (PET) . * Cannabidiol: Oral, per protocol dosage, single dose * Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience

Group II: Placebo Placebo Group 1 Intervention

After the screening procedures confirm participation in the research study, participants will be randomized one of two groups: * Participants in the placebo arm will complete questionnaire and then receive a single dose of placebo prior to diagnostic CT scan or positron emission tomography (PET) . * Placebo: Oral, per protocol dosage, single dose * Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Hans and Mavis Lopater Foundation

Collaborator

Trials

1

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11650394/

Cannabidiol for Scan-Related Anxiety in Women With ... The findings of this randomized clinical trial show that CBD can be used safely in women with advanced breast cancer and clinical anxiety.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04482244

RCT of CBD for Anxiety in Advanced Breast Cancer This research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12316815/

Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor ... Use of CBD was safe and tolerable for women with hormone receptor‐positive breast cancer. Associations were seen between baseline anxiety and ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14175-z

Cannabidiol as a novel therapeutic agent in breast cancer Preclinical studies have demonstrated the efficacy of CBD in reducing tumor growth and metastasis in various breast cancer models, particularly ...

5. renalandurologynews.com renalandurologynews.com/news/cannabidiol-safe-may-lower-anxiety-in-advanced-breast-cancer/

Cannabidiol Safe, May Lower Anxiety in Advanced Breast ... Cannabidiol is safe and may reduce anxiety levels in patients with advanced breast cancer 2 to 4 hours after ingestion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569602/

An Update on Safety and Side Effects of Cannabidiol The only observed side effects were reduced sucrose preference, reduced food consumption and body weight in the nonoperated animals treated with CBD (50 mg/kg).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820925000333

Characterizing Cannabidiol Use in a Breast Cancer ... This survey study aimed to characterize the use of and benefits from CBD use in patients with breast cancer, while also identifying barriers and limitations to ...

8. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/study-explores-whether-cbd-can-reduce-scan-related-anxiety

Study Explores Whether CBD Can Reduce Scan-Related ... The findings showed that CBD did not significantly change scan-related anxiety when compared to a placebo, but researchers did find that CBD was safe.