Fleege Nicole M G, Miller Elise A, Kidwell Kelley M, Zacharias Zeb R, Houtman Jon, Scheu Kelly, Kemmer Kathleen, Boehnke Kevin F, Henry N Lynn
University of Michigan Medical School, Ann Arbor, Michigan, USA.
Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
Cancer Med. 2025 Aug;14(15):e71117. doi: 10.1002/cam4.71117.
Aromatase inhibitor (AI) therapy reduces breast cancer recurrence risk. However, some patients stop treatment early because of AI-associated musculoskeletal symptoms (AIMSS). AIMSS is due in part to systemic inflammation. Cannabidiol (CBD) has anti-nociceptive and anti-inflammatory properties, making it a potential treatment option for AIMSS.
Women with stage 0-3 hormone receptor-positive breast cancer experiencing AIMSS enrolled in this phase 2 clinical trial. Patients received CBD (Epidiolex), titrated over 4 weeks to 100 mg BID, for a total of 15 weeks. Patient-reported outcomes were collected serially. The primary endpoint was the number of patients with at least a 2-point reduction in worst pain from baseline to 15 weeks. Statistical analysis was completed using paired t-tests and linear mixed models.
Of 39 eligible patients, 28 completed protocol-directed study treatment. Eleven discontinued treatment due to toxicity (n = 5) or per patient preference (n = 6). Seventeen of 39 patients met the primary endpoint (43.6%, 95% CI [28%, 60%]). Worst pain improved 0.13 per week of treatment (p < 0.001) for all patients; average improvement in worst pain was 1.95 points at the end of 15 weeks. Of the 28 patients who completed the study, average reduction in worst pain was 2.36 points (95% CI [-3.22, -1.49]) between baseline and Week 15.
Treatment with CBD was safe, tolerable, and associated with improvement in joint pain for a subset of patients. Additional studies are needed to further understand the impact of CBD on AIMSS and which patients are most likely to benefit from CBD treatment.
www.
gov: NCT04754399.
芳香化酶抑制剂（AI）疗法可降低乳腺癌复发风险。然而，一些患者因与AI相关的肌肉骨骼症状（AIMSS）而提前停止治疗。AIMSS部分归因于全身炎症。大麻二酚（CBD）具有抗伤害性和抗炎特性，使其成为AIMSS的一种潜在治疗选择。
患有0-3期激素受体阳性乳腺癌且出现AIMSS的女性参加了这项2期临床试验。患者接受CBD（ Epidiolex）治疗，在4周内滴定至每日两次100mg，共15周。连续收集患者报告的结局。主要终点是从基线到15周时最严重疼痛至少减轻2分的患者数量。使用配对t检验和线性混合模型完成统计分析。
39名符合条件的患者中，28名完成了方案指导的研究治疗。11名患者因毒性（n = 5）或患者个人意愿（n = 6）而停止治疗。39名患者中有17名达到主要终点（43.6%，95%CI[28%，60%]）。所有患者在治疗的每周中最严重疼痛改善0.13（p < 0.001）；在15周结束时，最严重疼痛的平均改善为1.95分。在完成研究的28名患者中，基线和第15周之间最严重疼痛的平均减轻为2.36分（95%CI[-3.22，-1.49]）。
CBD治疗安全、可耐受，并且对一部分患者的关节疼痛有改善作用。需要进一步研究以进一步了解CBD对AIMSS的影响以及哪些患者最可能从CBD治疗中获益。
www.
gov：NCT04754399 。
