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

50 Participants Needed

Trial Summary

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.

How does the drug CBD differ from other treatments for anxiety in breast cancer patients?

CBD (Cannabidiol) is unique because it is derived from cannabis and is being studied for its potential to reduce anxiety without the psychoactive effects associated with THC (the compound in cannabis that causes a 'high'). Unlike traditional anxiety medications, CBD is being explored for its natural origin and potential to offer relief with fewer side effects. ^{1 2 3 4 5}

What is the purpose of this trial?

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)

Research Team

Ilana M Braun, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Surgical impact on anxiety of patients with breast cancer: 12-month follow-up prospective longitudinal study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Prevalence and Persistence of Anxiety and Depression over Five Years since Breast Cancer Diagnosis-The NEON-BC Prospective Study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Trajectories of Anxiety and Depression Symptoms over Five Years since Breast Cancer Diagnosis: Results of the NEON-BC Prospective Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Anxiety and depression in breast cancer patients at start of adjuvant radiotherapy. Relations to age and type of surgery. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of depression and anxiety symptom trajectories in the 24 months following diagnosis of breast or gynaecologic cancer. [2019]