RCT of CBD for Anxiety in Advanced Breast Cancer

NCT04482244 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 19-886
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Advanced Breast Cancer; Anxiety; CBD

Keywords

Advanced Breast Cancer; Anxiety; CBD

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale

  Afraid is a negative mood subscale on the VAMS. Each subscale involves a 0 (neutral face or lack of endorsement) to 100 mm (mood face of extreme endorsement) a horizontal line with each pole having an associated mood descriptor. A raw score is a measure of distance from the neutral face (0 mm) to where the participant marks their mood to be in the moment. A linear transformation of a raw score is converted to a T-score and calculated to have a mean of 50 and an SD of 10. The manual provides a T-score conversion table based on sex and age bracket (18-54 years and 55-94 years). A 20T-score (+/-) difference in either direction between a pre- and posttest scores is interpreted as a reliable change in mood, and those differing by more than 30T-score (+/-) is interpreted as both a reliable and a clinically significant relevant threshold for change in mood. A change score for a given mood was calculated based on using T-scores of post-drug administration minus the pre-drug.

  1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 day

Secondary Outcomes (4)

• 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

• Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale

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

• Nausea Rate

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

• Numeric Pain Rating Scale (NPRS)

  Baseline , 1 day of the drug administration pre-dose

Study Arms (2)

Cannabidiol

EXPERIMENTAL

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

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Cannabidiol DRUG

Liquid taken orally

Also known as: Epidiolex, CBD

Cannabidiol

Placebo OTHER

Liquid taken orally

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Hans and Mavis Lopater Foundation: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Nayak MM, Chai P, Catalano PJ, Pirl WF, Tulsky JA, Tung SC, Lin NU, Andrade N, Johns S, Vaz C, Hughes M, Braun IM. Cannabidiol for Scan-Related Anxiety in Women With Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450391. doi: 10.1001/jamanetworkopen.2024.50391.

  PMID: 39680411 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Limitations and Caveats

it excluded men, so its findings cannot be extrapolated beyond women.

Results Point of Contact

• Title: Dr. Manan Nayak
• Organization: Dana-Farber Cancer Institute

manan_nayak@dfci.harvard.edu

617-632-5096

Study Officials

• Ilana Braun, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 22, 2020
• Study Start: January 19, 2022
• Primary Completion: March 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

US (1)