Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT04754399

Recruitment Status:

Recruiting

Sponsor:

University of Michigan Rogel Cancer Center

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There is 1 Location for this study

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University of Michigan Rogel Cancer Center
Ann Arbor Michigan, 48109, United States More Info
Cancer AnswerLine
Contact
800-865-1125
[email protected]
Norah L Henry, MD, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT04754399

Recruitment Status:

Recruiting

Sponsor:


University of Michigan Rogel Cancer Center

How clear is this clinincal trial information?

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