Advanced Breast CancerPhase 2NCT04482244
RCT of CBD for Anxiety in Advanced Breast Cancer
A Phase 2 study testing Cannabidiol in people with Advanced Breast Cancer and Anxiety, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer, Anxiety, CBD
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Randomized, Double-blind Phase II Study of a Single Dose of Cannabidiol (CBD) for Acute Anticipatory Anxiety in Advanced Breast Cancer
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)
Read the 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.
- Conditions
- Advanced Breast Cancer, Anxiety, CBD
- Being tested
- Cannabidiol, Placebo
- Keywords
- Advanced Breast Cancer, Anxiety, CBD
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Epidiolex, CBD
Liquid taken orally
PlaceboOther
Liquid taken orally
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
Confused, Sad, Angry, Tired, Tense are negative moods and Energetic and Happy are positive moods on VAMS. Each subscale involves a 0 (neutral face) to 100 mm (mood face) 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 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.
Measured: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day
Nausea Rate
Nausea and vomiting were measured using two items. Scale scores were calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a symptom scale or item represents a high level of symptomatology or problems.
Measured: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 week
Numeric Pain Rating Scale (NPRS)
pain intensity scale is scored from 0 to 10 (with 10 representing "worst possible" pain).
Measured: Baseline , 1 day of the drug administration pre-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start19 Jan 2022
- Primary completion1 Mar 2023
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hans and Mavis Lopater Foundation
- Responsible party
- Principal investigator, Ilana Braun, MD, Dana-Farber Cancer Institute
- Investigators
- Ilana Braun, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482244
- Sponsor's protocol ID
- 19-886
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2020
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39680411
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Phase II Study of a Single Dose of Cannabidiol (CBD) for Acute Anticipatory Anxiety in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04482244
- Acronym / sponsor ID
- 19-886
- Conditions
- Advanced Breast Cancer, Anxiety, CBD
- Keywords
- Advanced Breast Cancer, Anxiety, CBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Hans and Mavis Lopater Foundation
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: CannabidiolAfter 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 |
| Placebo | Placebo comparator | Other: PlaceboAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- At least mild anxiety typically experienced prior to oncologic scans (as measured by a prescreen survey item)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: Epidiolex, CBDLiquid taken orally | Drug | Cannabidiol |
| PlaceboLiquid taken orally | Other | Placebo |
Primary outcome
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
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.
4 secondary outcomes
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
Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
Time frame: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 day
Nausea Rate
Time frame: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 week
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline , 1 day of the drug administration pre-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39680411Nayak 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilana Braun, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Advanced Breast Cancer and Anxiety, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.