Status:
COMPLETED
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
American Society of Clinical Oncology
Conditions:
Arthralgia
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04754399
Start Date
April 16 2021
End Date
October 10 2023
Last Update
May 9 2025
Active Locations (1)
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1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109