Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

Conditions
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Arthralgia, Breast Cancer

Intervention / Treatment
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* Drug: Cannabidiol (CBD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal according to standard clinical criteria OR receiving concomitant LHRH agonist therapy. Taking aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment. Planning to take the same AI therapy for at least 15 weeks. New or worsening joint pain and/or myalgias since starting the AI therapy. Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months prior to enrollment. The complete list of inclusion criteria is provided in the protocol. Exclusion Criteria: Metastatic breast cancer. Planned surgery during the 15-week study period. Clinically significant laboratory abnormalities. Use of cannabidiol, THC, or marijuana (oral, inhaled, or topical) within the 6 weeks prior to enrollment. History of or currently has suicidal ideation or attempted suicide. History of seizure other than febrile seizures in childhood. The complete list of exclusion criteria is provided in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol (CBD)<br>Oral solution given 2x daily. | Drug: Cannabidiol (CBD)<br>* 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<br>* Other names: Epidiolex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in Brief Pain Inventory (BPI) worst pain from baseline to 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. | Baseline, week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with at least a 2-point reduction in BPI worst pain from baseline to 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. | Baseline, week 15 | 
| Number of patients with at least a 2-point reduction in BPI average pain from baseline to 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. | Baseline, week 15 | 
| Change in symptoms from baseline, as measured by the PROMIS-29+2 Profile v2.1 | 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. | Baseline, week 15 | 
| Number of treatment related adverse events | 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. | End of study (15 weeks) | 
| Number of participants with undetectable levels of estradiol | The number of participants with undetectable levels of estradiol circulating in blood plasma will be reported at baseline and 15 weeks. | Baseline and week 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabidiol