Phase 2
N=39
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Arthralgia · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04754399 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15 — -2.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cannabidiol (CBD) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15 |
-2.4 | — |
| SECONDARY Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15 |
17 | — |
| SECONDARY Number of Patients With at Least a 2-point Reduction in BPI Average Pain From Baseline to Week 15 |
14 | — |
| SECONDARY Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1 |
-6.5; -1.9; 2.0; -1.7; 5.7; -3.4 | — |
| SECONDARY Number of Treatment Related Adverse Events |
1; 1; 1; 1; 2; 1 | — |
| SECONDARY Number of Participants With Undetectable Levels of Estradiol |
8; 4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04754399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.