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RCT of CBD for Anxiety in Advanced Breast Cancer

Primary Purpose

Advanced Breast Cancer, Anxiety, CBD

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Breast Cancer focused on measuring Advanced Breast Cancer, Anxiety, CBD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 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
  • 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

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cannabidiol

Placebo

Arm Description

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 or positron emission tomography (PET) . Cannabidiol: Oral, per protocol dosage, single dose Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience

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 or positron emission tomography (PET) . Placebo: Oral, per protocol dosage, single dose Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience

Outcomes

Primary Outcome Measures

Change in Anxiety Score-Visual Analog Mood Scale (VAMs) anxiety subscale,
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

Number of Participants With Treatment-Related Adverse Events (PRO-CTCAE™) 5.
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
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
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
Pain levels (as measured by the PEG) 3 +/- 1 hour after study agent administration in patients with advanced cancer.
Numeric Pain Rating Scale (NPRS)
pain intensity scale is scored from 0 to 10 (with 10 representing "worst possible" pain).

Full Information

First Posted
July 20, 2020
Last Updated
August 21, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Hans and Mavis Lopater Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04482244
Brief Title
RCT of CBD for Anxiety in Advanced Breast Cancer
Official Title
Randomized, Double-blind Phase II Study of a Single Dose of Cannabidiol (CBD) for Acute Anticipatory Anxiety in Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
June 18, 2023 (Actual)
Study Completion Date
February 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Hans and Mavis Lopater Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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) or positron emission tomography (PET) to assess tumor burden. The name of the study drug(s) are: - Cannabidiol (CBD)
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) or positron emission tomography (PET) 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 learn if the drug can help reduce anxiety and can safely be given to participants with advanced breast cancer who are scheduled for a CT or PET 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 treatment, participants will complete questionnaires before and after receiving a single dose of CBD or placebo then undergo computed tomography (CT) scan or positron emission tomography (PET). Participants will be contacted by phone approximately a week later and interviewed about study drug consumption and the CT/PET 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer, Anxiety, CBD
Keywords
Advanced Breast Cancer, Anxiety, CBD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol
Arm Type
Experimental
Arm Description
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 or positron emission tomography (PET) . Cannabidiol: Oral, per protocol dosage, single dose Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 or positron emission tomography (PET) . Placebo: Oral, per protocol dosage, single dose Additional questionnaires 2 hours post scan and follow up via phone call 1 week regarding experience
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
Epidiolex, CBD
Intervention Description
Liquid taken orally
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Liquid taken orally
Primary Outcome Measure Information:
Title
Change in Anxiety Score-Visual Analog Mood Scale (VAMs) anxiety subscale,
Description
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.
Time Frame
1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 day
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events (PRO-CTCAE™) 5.
Description
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.
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
Title
Mood Changes
Description
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
Time Frame
Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day
Title
Nausea Rate
Description
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.
Time Frame
Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 week
Title
Pain Rate
Description
Pain levels (as measured by the PEG) 3 +/- 1 hour after study agent administration in patients with advanced cancer.
Time Frame
Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day
Title
Numeric Pain Rating Scale (NPRS)
Description
pain intensity scale is scored from 0 to 10 (with 10 representing "worst possible" pain).
Time Frame
Baseline , 1 day of the drug administration pre-dose

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilana Braun, MD
Phone
(617) 643-0576
Email
ibraun@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Braun, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana M Braun, MD
Phone
617-643-0576
Email
Ibraun@partners.org
First Name & Middle Initial & Last Name & Degree
Manan M Nayak, PhD
Phone
617-632-5096
Email
manan_nayak@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ilana M Braun, MD
First Name & Middle Initial & Last Name & Degree
William F Pirl, MD
First Name & Middle Initial & Last Name & Degree
Peter R Chai, MD
First Name & Middle Initial & Last Name & Degree
Manan M Nayak, PhD
First Name & Middle Initial & Last Name & Degree
Stephanie Tung, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

RCT of CBD for Anxiety in Advanced Breast Cancer

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