Status:
ACTIVE_NOT_RECRUITING
RCT of CBD for Anxiety in Advanced Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Hans and Mavis Lopater Foundation
Conditions:
Advanced Breast Cancer
Anxiety
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a randomized, double-blind, placebo-controlled Phase II trial of a single dose of CBD for acute anticipatory anxiety in patients with advanced breast cancer undergoing computed tomography (CT)...
Eligibility Criteria
Inclusion
- Diagnosis of Stage IV or metastatic breast cancer
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Participants must have adequate organ and marrow function at baseline as defined below:
- total bilirubin \>2 times institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- Baseline anxiety as measured by GAD-7 ≥5
- At least mild anxiety typically experienced prior to oncologic scans (as measured by a prescreen survey item)
- Computed tomography (CT) or positron emission tomography (PET) to assess tumor burden scheduled for within 48 hours of study drug administration
- No cannabis, delta-9-tetrahydrocannabinol or cannabidiol use within 24-hours of study drug administration.
- No benzodiazepine consumption within 8 hours of study drug administration (e.g.,nighttime benzodiazepine use permissible)
- No driving for 12 hours following study drug administration.
- English proficiency
- The effects of cannabidiol (Epidiolex) on the developing human fetus are unknown. For this reason and because cannabis is known to be teratogenic, women of child-bearing potential must test as nonpregnant prior to entering the study. The study team will encourage women of child-bearing age and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 1 week after cannabidiol (Epidiolex) consumption. Women either age \> 54 years or documented to be in menopause or status post hysterectomy will not be required to obtain bHCG.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cannabidiol (Epidiolex) or placebo (which contains sesame, corn and gluten)
- History of current clobazam or valproic acid use
- Current uncontrolled illness, for instance sepsis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Current use of antiretroviral therapy
- Participants with psychiatric illness or social situations that would limit compliance with study requirements
- Current hepatocellular carcinoma, or documented history of difficult to control diabetes -- Active participation in a clinical drug trial
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04482244
Start Date
January 19 2022
End Date
December 1 2026
Last Update
July 29 2025
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115