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

University of Michigan Rogel Cancer Center

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Arthralgia

Treatments

Drug: Cannabidiol (CBD)

Study type

Interventional

Funder types

Other

Identifiers

NCT04754399

HUM00182109 (Other Identifier)

UMCC 2020.041

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.