Trial Outcomes & Findings for RCT of CBD for Anxiety in Advanced Breast Cancer (NCT NCT04482244)
NCT ID: NCT04482244
Last Updated: 2025-07-29
Results Overview
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.
ACTIVE_NOT_RECRUITING
PHASE2
60 participants
1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 day
2025-07-29
Participant Flow
At the cancer center, medical records were screened between November 2, 2021, and March 1, 2023, and obtained physician approval prior to contacting potential participants. Interested women were consented and completed the survey and laboratory assessments necessary to determine eligibility. Survey assessments included demographics, cannabis history, the validated GAD-7 scale, and history of scan-related anxiety.
501 screened. 310 excluded: 76 on clinical drug trial, 64 not responding, 37 declined,133 excluded for other reasons. Of 191 meeting eligibility, 54 without scheduled scan, 40 had scan too soon, 27 denied anxiety, \& 3 excluded for other reasons. 67 scheduled for consent: 3 lost interest, 3 denied anxiety, \& 1 did not attend. 60 patients consented, but 10 were not randomized, because they didn't meet eligibility criteria. 50 total participants were eligible, consented and randomized.
Participant milestones
| Measure |
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 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
Cannabidiol: Liquid taken orally
|
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 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
Placebo: Liquid taken orally
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RCT of CBD for Anxiety in Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Cannabidiol
n=25 Participants
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
Cannabidiol: Liquid taken orally
|
Placebo
n=25 Participants
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
Placebo: Liquid taken orally
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
57 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black of African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Declined
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
baseline anxiety score
Mild to moderate
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
baseline anxiety score
Severe
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 dayAfraid 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.
Outcome measures
| Measure |
Cannabidiol
n=25 Participants
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
Cannabidiol: Liquid taken orally
|
Placebo
n=25 Participants
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
Placebo: Liquid taken orally
|
|---|---|---|
|
Change in Anxiety Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
|
-19.1 T-Score
Standard Deviation 15.4
|
-15.0 T-Score
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 1 day of the drug administration pre-dose (T2) and 3 +/- 1 hour after drug administration (T3) up to 1 weeks post ingestionMeasured 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.
Outcome measures
| Measure |
Cannabidiol
n=25 Participants
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
Cannabidiol: Liquid taken orally
|
Placebo
n=25 Participants
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
Placebo: Liquid taken orally
|
|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events (PRO-CTCAE™) 5.
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 dayConfused, 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.
Outcome measures
| Measure |
Cannabidiol
n=25 Participants
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
Cannabidiol: Liquid taken orally
|
Placebo
n=25 Participants
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
Placebo: Liquid taken orally
|
|---|---|---|
|
Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
Confused
|
0.9 T-Score
Standard Deviation 6.7
|
-0.1 T-Score
Standard Deviation 4.9
|
|
Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
Sad
|
-5.8 T-Score
Standard Deviation 11.2
|
-8.9 T-Score
Standard Deviation 11.4
|
|
Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
Angry
|
-3.6 T-Score
Standard Deviation 8.8
|
-6.1 T-Score
Standard Deviation 10.5
|
|
Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
Energetic
|
-1.8 T-Score
Standard Deviation 8.7
|
-2.1 T-Score
Standard Deviation 13.6
|
|
Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
Tired
|
-2.0 T-Score
Standard Deviation 9.8
|
-3.6 T-Score
Standard Deviation 10.1
|
|
Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
Happy
|
3.3 T-Score
Standard Deviation 8.7
|
2.6 T-Score
Standard Deviation 9.3
|
|
Change in Mood Score-Visual Analog Mood Scale (VAMs) Anxiety Subscale
Tense
|
-11.6 T-Score
Standard Deviation 12.6
|
-10.4 T-Score
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline through 3 +/- 1 hour after drug administration (T3) up to 1 weekNausea 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.
Outcome measures
| Measure |
Cannabidiol
n=25 Participants
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
Cannabidiol: Liquid taken orally
|
Placebo
n=25 Participants
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
Placebo: Liquid taken orally
|
|---|---|---|
|
Nausea Rate
NV Score Pre-drug
|
6.0 score on a scale
Standard Deviation 8.2
|
6.7 score on a scale
Standard Deviation 13.6
|
|
Nausea Rate
NV Score Post-drug
|
7.3 score on a scale
Standard Deviation 15.3
|
1.3 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline , 1 day of the drug administration pre-dosepain intensity scale is scored from 0 to 10 (with 10 representing "worst possible" pain).
Outcome measures
| Measure |
Cannabidiol
n=25 Participants
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
Cannabidiol: Liquid taken orally
|
Placebo
n=25 Participants
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
Placebo: Liquid taken orally
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
|
-0.88 score on a scale
Standard Deviation 1.45
|
-0.88 score on a scale
Standard Deviation 1.33
|
Adverse Events
Cannabidiol
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cannabidiol
n=25 participants at risk
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
Cannabidiol: Liquid taken orally
|
Placebo
n=25 participants at risk
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
Placebo: Liquid taken orally
|
|---|---|---|
|
General disorders
Pain
|
4.0%
1/25 • Number of events 1 • 1 week follow up
|
0.00%
0/25 • 1 week follow up
|
|
General disorders
Nausea
|
4.0%
1/25 • Number of events 1 • 1 week follow up
|
0.00%
0/25 • 1 week follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place