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Study of Cannabidol to examine the safety and efficacy of 15 weeks of CBD in postmenopausal women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Investigators are looking to see if patients with joint pain see improvement with the use of CBD.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-05-09
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
week 1: 25 mg twice daily, approximately 12 hours apart, with food week 2: 50 mg twice daily, approximately 12 hours apart, with food week 3: 75 mg twice daily, approximately 12 hours apart, with food week 4+: 100 mg twice daily, approximately 12 hours apart, with food
EpidiolexSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, absolute change for only one BPI item will be assessed, "joint pain and stiffness at its worst in the last week".
Population: 11 patients missing data
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) | 28 | -2.4 | -3.22 to -1.49 |
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness at its worst in the last week", will be assessed.
Population: 11 patients missing data
| Group | N | Value | Spread / interval |
|---|---|---|---|
Eligibility
primary outcomes
Time frame: Baseline, week 15
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, absolute change for only one BPI item will be assessed, "joint pain and stiffness at its worst in the last week".
secondary outcomes
Time frame: Baseline, week 15
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness at its worst in the last week", will be assessed.
Time frame: Baseline, week 15
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness on the average", will be assessed.
Time frame: Baseline, week 15
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 (PROPr) is a validated questionnaire to assess patient-reported symptoms over the past 7 days in 7 PROMIS domains on a scale of 1 (worst) to 5 (best). Raw scores for each domain are calculated and then converted to a T-score, with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured: for fatigue, sleep disturbance, depression, and anxiety, higher scores represent worse symptoms; for physical functioning, ability to participate in social roles and activities, and cognitive function-abilities, higher scores mean better function.
Time frame: End of study (15 weeks)
Treatment related adverse events include those that are determined to be possibly, probably or definitely related to the study drug. Number of events will be reported by dose level and grade, per Common Terminology Criteria for Adverse Events (CTCAE) v.5.
Time frame: Baseline and week 15
The number of participants with undetectable levels of estradiol circulating in blood plasma will be reported at baseline and 15 weeks.
Publications
| Cannabidiol (CBD) |
| 28 |
| 17 |
| - |
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness on the average", will be assessed.
Population: 11 patients missing data
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) | 28 | 14 | - |
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 (PROPr) is a validated questionnaire to assess patient-reported symptoms over the past 7 days in 7 PROMIS domains on a scale of 1 (worst) to 5 (best). Raw scores for each domain are calculated and then converted to a T-score, with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured: for fatigue, sleep disturbance, depression, and anxiety, higher scores represent worse symptoms; for physical functioning, ability to participate in social roles and activities, and cognitive function-abilities, higher scores mean better function.
Population: 11 patients missing data
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) | 28 | -6.5 | 7.2 |
| Cannabidiol (CBD) | 28 | -1.9 | 2.1 |
| Cannabidiol (CBD) | 28 | 2.0 | 1.2 |
| Cannabidiol (CBD) | 28 | -1.7 | 4.5 |
| Cannabidiol (CBD) | 28 | 5.7 | 8.0 |
| Cannabidiol (CBD) | 28 | -3.4 | 6.0 |
| Cannabidiol (CBD) | 28 | 3.9 | 5.3 |
| Cannabidiol (CBD) | 28 | -3.3 | 6.9 |
| Cannabidiol (CBD) | 28 | -3.7 | 6.6 |
Treatment related adverse events include those that are determined to be possibly, probably or definitely related to the study drug. Number of events will be reported by dose level and grade, per Common Terminology Criteria for Adverse Events (CTCAE) v.5.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 2 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 2 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
| Cannabidiol (CBD) | 39 | 1 | - |
The number of participants with undetectable levels of estradiol circulating in blood plasma will be reported at baseline and 15 weeks.
Population: All enrolled patients would be analyzed; however, 3 samples are missing for baseline and 9 for week 15
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Cannabidiol (CBD) | 36 | 8 | - |
| Cannabidiol (CBD) | 36 | 4 | - |
1 subject was enrolled but deemed ineligible before starting treatment
| Milestone | Cannabidiol (CBD) |
|---|---|
| STARTED | 39 |
| COMPLETED | 28 |
| NOT COMPLETED | 11 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Agitation | Psychiatric disorders | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Alanine aminotransferase increased | Investigations | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 1 / 39 |
| Anorexia | Metabolism and nutrition disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 1 / 39 |
| Anxiety | Psychiatric disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 1 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Arthralgia | Musculoskeletal and connective tissue disorders | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Back pain | Musculoskeletal and connective tissue disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 1 / 39 · CBD- Week 4: 0 / 39 |
| Bladder infection | Infections and infestations | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 1 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Blood bilirubin increased | Investigations | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Chronic kidney disease | Renal and urinary disorders | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Creatinine increased | Investigations | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 1 / 39 · CBD- Week 3: 1 / 39 · CBD- Week 4: 0 / 39 |
| Depression | Psychiatric disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 1 / 39 · CBD- Week 4: 0 / 39 |
| Diarrhea | Gastrointestinal disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 1 / 39 · CBD- Week 4: 1 / 39 |
| Dizziness | Nervous system disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 1 / 39 |
| Fatigue | General disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 1 / 39 · CBD- Week 4: 1 / 39 |
| Flushing | Vascular disorders | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Gastroesophageal reflux disease | Gastrointestinal disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 1 / 39 |
| Headache | Nervous system disorders | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 1 / 39 · CBD- Week 4: 1 / 39 |
| Hematuria | Renal and urinary disorders | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Hyperglycemia | Metabolism and nutrition disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 1 / 39 · CBD- Week 4: 0 / 39 |
| Hyponatremia | Metabolism and nutrition disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 1 / 39 · CBD- Week 4: 0 / 39 |
| Insomnia | Psychiatric disorders | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Memory impairment | Nervous system disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 1 / 39 |
| Myalgia | Musculoskeletal and connective tissue disorders | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Nausea | Gastrointestinal disorders | Cannabidiol (CBD)- Week 1: 2 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 2 / 39 |
| Neck pain | Musculoskeletal and connective tissue disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 1 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Oral pain | Gastrointestinal disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 1 / 39 |
| Peripheral motor neuropathy | Nervous system disorders | Cannabidiol (CBD)- Week 1: 0 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 2 / 39 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Cannabidiol (CBD)- Week 1: 2 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 0 / 39 · CBD- Week 4: 0 / 39 |
| Stomach pain | Gastrointestinal disorders | Cannabidiol (CBD)- Week 1: 1 / 39 · CBD- Week 2: 0 / 39 · CBD- Week 3: 1 / 39 · CBD- Week 4: 1 / 39 |