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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
Adequate organ and marrow function at baseline as defined below:
ECOG performance status ≤2 (Karnofsky ≥60%)
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 weeks post ingestion
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My organs and bone marrow are working well.
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I can care for myself but may not be able to do active work.
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I won't drive for 12 hours after taking the study medication.
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I am 18 years old or older.
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I am scheduled for a CT or PET scan to check my cancer within 2 days of starting the study drug.
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I am not pregnant and will use birth control during the study.
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I have not used cannabis or related products within 24 hours before taking the study drug.
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My breast cancer has spread to other parts of my body.
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I haven't taken any benzodiazepines within 8 hours before the study drug.
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I agree to use contraception while on this trial.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Anxiety Score-Visual Analog Mood Scale (VAMs) anxiety subscale
Secondary outcome measures
Mood Changes
Nausea Rate
Number of Participants With Treatment-Related Adverse Events (PRO-CTCAE™) 5.
+2 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617
38%
Tiredness
24%
Drowsiness
24%
Poor sleep
22%
Constipation
18%
Poor Appetite
16%
Dizziness
9%
Headache
7%
Nausea
7%
Diarrhea
4%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
CBD Oil Group
Control 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

Find a Location

Who is running the clinical trial?

Hans and Mavis Lopater FoundationUNKNOWN
Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,356 Total Patients Enrolled
141 Trials studying Breast Cancer
22,571 Patients Enrolled for Breast Cancer
Ilana Braun, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04482244 — Phase 2
Breast Cancer Research Study Groups: Cannabidiol, Placebo
Breast Cancer Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT04482244 — Phase 2
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04482244 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available in this clinical undertaking?

"Accurate. According to information found on clinicaltrials.gov, this medical examination is still seeking participants since it was initially posted in January 19th 2022 and last modified on February 2nd of the same year. The desired number of patients for this study are 50 from a single site location."

Answered by AI

Has the FDA sanctioned Cannabidiol for medicinal use?

"Due to the Phase 2 status of this trial, there is only some evidence indicating the safety profile of Cannabidiol. Thus, it received a score of two on our team's metric from 1-3."

Answered by AI

Are there any other experiments that have explored Cannabidiol's efficacy?

"Presently, 79 clinical trials for Cannabidiol are underway with 16 of those studies having progressed to Phase 3. The bulk of these experiments are centred in Ribeirao Preto, Sao Paulo; however, research is being conducted across 290 locations worldwide."

Answered by AI

How many individuals are currently undergoing treatment within this experiment?

"Yes, clinicaltrials.gov data indicate that this trial is currently enrolling patients. This research initiative was first posted on January 19th 2022 and has been most recently updated on February 2nd of the same year. 50 participants are being admitted from a solitary medical facility."

Answered by AI
~16 spots leftby Mar 2025