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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Rogel Cancer Center
• Collaborator: American Society of Clinical Oncology
• Treatments: Cannabidiol; Epidiolex

Criteria

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.