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Cannabinoid

CBD for Anxiety in Breast Cancer

Phase 2

Waitlist Available

Led By Ilana Braun, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤2 (Karnofsky ≥60%)

Age ≥18 years

Must not have

Current uncontrolled illness, for instance sepsis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia

Current hepatocellular carcinoma, or documented history of difficult to control diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day of the drug administration pre-dose (t2) and 3 +/- 1 hour after drug administration (t3) up to 1 day

Summary

This trial is studying how well a single dose of cannabidiol (CBD) helps manage anticipatory anxiety in participants with advanced breast cancer who are about to have computed tomography (CT) or positron emission tomography (PET) scans to assess tumor burden.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of CBD include tiredness, diarrhea, changes in appetite/weight, and potential interaction with other medications. The specific formulation may also cause reactions due to its sesame, corn and gluten content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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My breast cancer has spread to other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am allergic to cannabidiol or ingredients in the placebo like sesame, corn, and gluten.

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I am currently using clobazam or valproic acid.

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I am currently taking medication for HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 3 +/- 1 hour after drug administration (t3) up to 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 3 +/- 1 hour after drug administration (t3) up to 1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 3 +/- 1 hour after drug administration (t3) up to 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Anxiety Score-Visual Analog Mood Scale (VAMs) anxiety subscale

Secondary study objectives

Mood Changes

Nausea Rate

Number of Participants With Treatment-Related Adverse Events (PRO-CTCAE™) 5.

+1 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617

29%

Tiredness

20%

Constipation

18%

Drowsiness

11%

Poor sleep

11%

Dizziness

Poor Appetite

Headache

Nausea

Itching

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

CBD Oil Group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CannabidiolExperimental Treatment1 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: PlaceboPlacebo Group1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

2021

Completed Phase 3

~1010

0 / 8Eligibility criteria met