Cannabidiol for CBD

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
CBD+4 More
Cannabidiol - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • CBD
  • Breast
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for CBD

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 weeks post ingestion

Day 1
Change in Anxiety Score-Visual Analog Mood Scale (VAMs) anxiety subscale
Week 1
Number of Participants With Treatment-Related Adverse Events (PRO-CTCAE™) 5.
Day 1
Pain
Pain intensity scale (PINS)
Day 1
Mood Changes
Pain
Week 1
Nausea Rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for CBD

Side Effects for

Cannabidiol
60%Temporary increased seizures
40%Behavioral Issues
20%Increased aspartate aminotransferase liver function test
20%Right eye exotropia and redness/intermittent exotropia without redness
20%Facial Skin Infection
20%Tiredness
20%Left Eye Vertical Nystagmus
20%Pneumonia
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT02332655) in the Cannabidiol ARM group. Side effects include: Temporary increased seizures with 60%, Behavioral Issues with 40%, Increased aspartate aminotransferase liver function test with 20%, Right eye exotropia and redness/intermittent exotropia without redness with 20%, Facial Skin Infection with 20%.

Trial Design

2 Treatment Groups

Cannabidiol
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Cannabidiol · Has Placebo Group · Phase 2

Cannabidiol
Drug
Experimental Group · 1 Intervention: Cannabidiol · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 day of the drug administration pre-dose (t2) and 3 +/- 1 hour after drug administration (t3) up to 1 weeks post ingestion

Who is running the clinical trial?

Hans and Mavis Lopater FoundationUNKNOWN
Dana-Farber Cancer InstituteLead Sponsor
1,012 Previous Clinical Trials
393,309 Total Patients Enrolled
Ilana Braun, MDPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of Stage IV or metastatic breast cancer.
You have a score of ≤2 on the ECOG performance status scale.
AST/ALT ratio is less than 3 times institutional ULN.
You have a baseline anxiety level of at least 5 on the Generalized Anxiety Disorder 7 (GAD-7) scale.
Benzodiazepine consumption within 8 hours of study drug administration (e.g.
A study drug is administered to assess tumor burden.
At least mild anxiety typically experienced prior to oncologic scans (as measured by a prescreen survey item).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.