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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

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

NCT ID

NCT04482244

First Posted

July 20, 2020

Last Updated

August 21, 2023

Sponsor

Dana-Farber Cancer Institute

Collaborators

Hans and Mavis Lopater Foundation

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

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

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

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

Time Frame

Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day

Title

Nausea Rate

Description

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

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

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

Ibraun@partners.org

First Name & Middle Initial & Last Name & Degree

Manan M Nayak, PhD

Phone

617-632-5096

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

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RCT of CBD for Anxiety in Advanced Breast Cancer

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