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

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

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.

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.