RCT of CBD for Anxiety in Advanced Breast Cancer
Keywords
Abstract
Description
This is a randomized, double-blind, placebo-controlled trial of a single dose of CBD for acute anticipatory anxiety in patients with advanced breast cancer undergoing computed tomography (CT) scan to assess tumor burden.
The research study investigates use of CBD to manage anxiety prior to an oncologic imaging scan. CBD is a component of the cannabis sativa (marijuana) plant and of hemp. Studies of CBD have led to its approval by the Food and Drug Administration for certain childhood seizure disorders. Researchers have also been studying the use of CBD to manage anxiety and pain.
This study is designed to find out if the drug can help reduce anxiety and can safely be given to participants with advanced breast cancer who are scheduled for a CT scan.
- After screening procedures confirm participation in the research study, participants will be "randomized" into one of two study groups: one group will receive CBD, the other group will receive a placebo of flavored corn syrup.
- Randomization means that participants are put into a group by chance. Neither the participant nor the research team will choose participant group assignment.
- Participants will have a 66% chance of receiving a single dose of CBD.
- Participants will have a 33% chance of receiving a single dose of placebo.
- On the day of scheduled CT scans, participants will complete questionnaires before and after receiving a single dose of CBD or placebo then undergo computed tomography (CT) scan. Participants will be contacted by phone approximately a week later and interviewed about study drug consumption and the CT scan experience.
This study is supported by funding from the Hans and Mavis Lopater Foundation.
Approximately 50 people are anticipated to take part in this study.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved CBD to manage anxiety but it has been approved for use in children with some seizure disorders.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 07/19/2020 |
| Estimated Enrollment Submitted: | 07/20/2020 |
| First Posted: | 07/21/2020 |
| Last Update Submitted: | 07/20/2020 |
| Last Update Posted: | 07/21/2020 |
| Actual Study Start Date: | 09/17/2020 |
| Estimated Primary Completion Date: | 02/17/2023 |
| Estimated Study Completion Date: | 02/17/2024 |
Condition or disease
Intervention/treatment
Drug: Cannabidiol
Other: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Cannabidiol 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.
Cannabidiol: Oral, per protocol dosage, single dose
Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience | Drug: Cannabidiol Liquid taken orally |
| Placebo Comparator: Placebo 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.
Placebo: Oral, per protocol dosage, single dose
Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience | Other: Placebo Liquid taken orally |
Eligibility Criteria
| Ages Eligible for Study | 21 Years To 21 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Diagnosis of Stage IV or metastatic breast cancer - Age ≥21 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 - creatinine within normal institutional limits OR - creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. - 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 with contrast to assess tumor burden scheduled for day of study - No cannabinoid use (inclusive of cannabis, tetrahydrocannabinol or cannabidiol) within 24 hours of study drug administration. - No benzodiazepine consumption within 12 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 month after cannabidiol (Epidiolex) consumption. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - 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 - "Severe Risk" AUDIT-C score - 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, liver metastases, or documented history of difficult to control diabetes |
Outcome
Primary Outcome Measures
1. Change in Anxiety Score-Visual Analog Mood Scale (VAMs) anxiety subscale, [1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 day]
Secondary Outcome Measures
1. Number of Participants With Treatment-Related Adverse Events (PRO-CTCAE™) 5. [1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 weeks post ingestion]
2. Mood Changes [Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day]
3. Nausea Rate [Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 week]
4. Pain Rate [Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day]
5. Pain intensity scale (PINS) [Baseline , 1 day of the drug administration pre-dose]
