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Trial record 4 of 22 for:    cbd | anxiety

RCT of CBD for Anxiety in Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04482244
Recruitment Status : Not yet recruiting
First Posted : July 22, 2020
Last Update Posted : April 20, 2021
Sponsor:
Collaborator:
Hans and Mavis Lopater Foundation
Information provided by (Responsible Party):
Ilana Braun, MD, Dana-Farber Cancer Institute

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) 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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

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
Other Names:
  • Epidiolex
  • CBD

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


  4. 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.

  5. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Ilana Braun, MD (617) 643-0576 ibraun@partners.org

Locations
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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         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Hans and Mavis Lopater Foundation
Investigators
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Principal Investigator: Ilana Braun, MD Dana-Farber Cancer Institute
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Responsible Party: Ilana Braun, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04482244    
Other Study ID Numbers: 19-886
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ilana Braun, MD, Dana-Farber Cancer Institute:
Advanced Breast Cancer
Anxiety
CBD
Additional relevant MeSH terms:
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Breast Neoplasms
Anxiety Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Mental Disorders
Epidiolex
Anticonvulsants