Cannabidiol for the Treatment of Aromatase Inhibitor-Associated Arthralgias

Inclusion Criteria

• Female subject aged >= 18 years who is postmenopausal according to standard clinical criteria or who has been receiving concomitant luteinizing hormone-releasing hormone (LHRH) agonist therapy
• Taking the currently prescribed 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, with worst pain score of at least 4 out of 10 on the BPI over the 7 days prior to enrollment
• Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months prior to enrollment. Completion of axillary surgery as indicated (not required)
• Completion of chemotherapy, if given. Concurrent use of luteinizing hormone-releasing hormone analogue (LHRHa) therapy, anti-HER2 therapy, bisphosphonate therapy, PARP inhibitor therapy, and CDK4/6 inhibitor therapy is permitted
• Patients receiving treatment with non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, opioids, duloxetine, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Able to self-complete questionnaires in English
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

• Metastatic breast cancer
• Planned surgery during the 15-week study period
• Alanine aminotransferase/aspartate aminotransferase (ALT/AST) > 3 x upper limit of normal (ULN) (obtained =< 28 days of registration)
• Bilirubin > 1.5 x ULN. If known Gilbert’s syndrome, bilirubin may not be > 2 x ULN
• Creatinine > 1.5 x ULN (obtained =< 28 days of registration)
• Hemoglobin < 9 g/dL (obtained =< 28 days of registration)
• History of or currently has suicidal ideation or attempted suicide
• History of seizure other than febrile seizures in childhood
• Current use of valproate or clobazam. If patient takes valproate or clobazam, should discontinue 7 days prior to enrollment
• Use of cannabidiol, tetrahydrocannabinol (THC), or marijuana (oral, inhaled, or topical) within the 6 weeks prior to enrollment
• Known allergy or hypersensitivity to CBD or any of the excipients in the medication, including sesame
• Unable to take oral medications
• Pregnant or breast feeding
• Any medical condition that would interfere with the absorption of study medication. Prior gastric bypass is permitted
• Concurrent medical or arthritis disease such as active rheumatoid arthritis or inflammatory arthritis that could confound or interfere with evaluation of pain or efficacy. Patients with osteoarthritis are eligible
• Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen