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NCT Number: NCT04754399

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

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.

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Key information

Conditions

Arthralgia Breast Cancer Breast Diseases Breast Neoplasms Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol (CBD)

Drug

week 1: 25 mg twice daily, approximately 12 hours apart, with food

week 2: 50 mg twice daily, approximately 12 hours apart, with food

week 3: 75 mg twice daily, approximately 12 hours apart, with food

week 4+: 100 mg twice daily, approximately 12 hours apart, with food

Other names: Epidiolex

Primary outcomes

  1. Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15

    Time frame: Baseline, week 15

    The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, absolute change for only one BPI item will be assessed, "joint pain and stiffness at its worst in the last week".

Secondary outcomes

  1. Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15

    Time frame: Baseline, week 15

    The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness at its worst in the last week", will be assessed.

  2. Number of Patients With at Least a 2-point Reduction in BPI Average Pain From Baseline to Week 15

    Time frame: Baseline, week 15

    The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness on the average", will be assessed.

  3. Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1

    Time frame: Baseline, week 15

    The Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 (PROPr) is a validated questionnaire to assess patient-reported symptoms over the past 7 days in 7 PROMIS domains on a scale of 1 (worst) to 5 (best). Raw scores for each domain are calculated and then converted to a T-score, with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured: for fatigue, sleep disturbance, depression, and anxiety, higher scores represent worse symptoms; for physical functioning, ability to participate in social roles and activities, and cognitive function-abilities, higher scores mean better function.

  4. Number of Treatment Related Adverse Events

    Time frame: End of study (15 weeks)

    Treatment related adverse events include those that are determined to be possibly, probably or definitely related to the study drug. Number of events will be reported by dose level and grade, per Common Terminology Criteria for Adverse Events (CTCAE) v.5.

  5. Number of Participants With Undetectable Levels of Estradiol

    Time frame: Baseline and week 15

    The number of participants with undetectable levels of estradiol circulating in blood plasma will be reported at baseline and 15 weeks.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • American Society of Clinical Oncology

Registry information

Official study title

Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2021
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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