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

  • STATUS
    Recruiting
  • End date
    Feb 15, 2023
  • participants needed
    44
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 16 May 2021

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.

Details
Condition Arthralgia, Chronic Leg Pain, Breast Cancer, Breast Cancer, Pain, Post-Surgical Pain, Pain (Pediatric), Pain, Chronic Leg Pain, Post-Surgical Pain, Breast Cancer Diagnosis, Pain (Pediatric), breast carcinoma, joint pain, pain, joint, arthralgias, cancer, breast
Treatment Cannabidiol (CBD)
Clinical Study IdentifierNCT04754399
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

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
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