RCT of CBD for Anxiety in Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04482244|
Recruitment Status : Not yet recruiting
First Posted : July 22, 2020
Last Update Posted : April 20, 2021
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) scan to assess tumor burden.
The name of the study drug(s) are:
- Cannabidiol (CBD)
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer Anxiety CBD||Drug: Cannabidiol Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double-blind Phase II Study of a Single Dose of Cannabidiol (CBD) for Acute Anticipatory Anxiety in Advanced Breast Cancer|
|Estimated Study Start Date :||July 18, 2021|
|Estimated Primary Completion Date :||July 18, 2023|
|Estimated Study Completion Date :||February 18, 2024|
After screening procedures confirm participation in the research study, participants will be randomized one of two groups:
Liquid taken orally
Placebo Comparator: Placebo
After the screening procedures confirm participation in the research study, participants will be randomized one of two groups:
Liquid taken orally
- Change in Anxiety Score-Visual Analog Mood Scale (VAMs) anxiety subscale, [ Time Frame: 1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 day ]The change in anxiety score will be calculated for each patient and a Wilcoxon rank sum test will be used to assess whether the change score is different among patients randomized to CBD as compared to placebo.
- Number of Participants With Treatment-Related Adverse Events (PRO-CTCAE™) 5. [ Time Frame: 1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 weeks post ingestion ]Measured using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) and a qualitative assessment, patient-reported side effects and acceptability of taking oral CBD (versus placebo) for managing anticipatory anxiety.
- Mood Changes [ Time Frame: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day ]Measured by VAMS subscales-The Visual Analog Mood Scale (VAMS) a validated in-the-moment measure of eight specific mood states: Afraid, Confused, Sad, Angry, Energetic, Tired, Happy, and Tense. Subjects are asked to mark their mood along this continuum. The measure is scored using a metric ruler
- Nausea Rate [ Time Frame: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 week ]
Measured by the European Organisation for Research and Treatment of Cancer core quality of life questionnaire-nausea subscale.
The EORTC-QLQc30 is a widely used and validated measure of symptom burden.
- Pain Rate [ Time Frame: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day ]Pain levels (as measured by the PEG) 3 +/- 1 hour after study agent administration in patients with advanced cancer.
- Pain intensity scale (PINS) [ Time Frame: Baseline , 1 day of the drug administration pre-dose ]pain intensity scale is scored from 0 to 10 (with 10 representing "worst possible" pain).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04482244
|Contact: Ilana Braun, MD||(617) email@example.com|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Contact: Ilana M Braun, MD 617-643-0576 Ibraun@partners.org|
|Principal Investigator: Ilana M Braun, MD|
|Principal Investigator:||Ilana Braun, MD||Dana-Farber Cancer Institute|