Clinical trial · Interventional
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
NCT04754399CI-TRIAL-00089468completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthralgia | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cannabidiol (CBD) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cannabidiol (CBD)
- description
- Oral solution given 2x daily.
- interventionNames
- Drug: Cannabidiol (CBD)
Primary outcomes (1)
- measure
- Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15
- timeFrame
- Baseline, week 15
- description
- 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 (5)
- measure
- Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFleege NMG, Miller EA, Kidwell KM, Zacharias ZR, Houtman J, Scheu K, Kemmer K, Boehnke KF, Henry NL. Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer. Cancer Med. 2025 Aug;14(15):e71117. doi: 10.1002/cam4.71117. PMID 40751295