Pilot Study of Cannabidiol for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Breast Cancer

IF 3.1 2区 医学 Q2 ONCOLOGY
Cancer Medicine Pub Date : 2025-08-01 DOI:10.1002/cam4.71117
Nicole M. G. Fleege, Elise A. Miller, Kelley M. Kidwell, Zeb R. Zacharias, Jon Houtman, Kelly Scheu, Kathleen Kemmer, Kevin F. Boehnke, N. Lynn Henry
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Abstract

Introduction

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.

Methods

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.

Results

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.

Conclusion

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.

Trial Registration

www.clinicaltrials.gov: NCT04754399

Abstract Image

大麻二酚治疗乳腺癌芳香化酶抑制剂相关肌肉骨骼症状的初步研究
芳香酶抑制剂(AI)治疗可降低乳腺癌复发风险。然而,一些患者由于ai相关的肌肉骨骼症状(AIMSS)而早期停止治疗。AIMSS的部分原因是全身性炎症。大麻二酚(CBD)具有抗伤害和抗炎特性,使其成为AIMSS的潜在治疗选择。方法0-3期激素受体阳性乳腺癌伴AIMSS患者入组2期临床试验。患者接受CBD (Epidiolex),在4周内滴定至100 mg BID,共15周。患者报告的结果按顺序收集。主要终点是从基线到15周最严重疼痛至少减少2个点的患者数量。采用配对t检验和线性混合模型完成统计分析。结果39例符合条件的患者中,28例完成了方案导向的研究治疗。11例因毒性(n = 5)或每个患者偏好(n = 6)而停止治疗。39例患者中有17例达到了主要终点(43.6%,95% CI[28%, 60%])。所有患者的最严重疼痛每周改善0.13 (p < 0.001);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,从基线到第15周,最严重疼痛平均减少2.36点(95% CI[- 3.22, - 1.49])。结论:CBD治疗是安全、耐受的,并且与部分患者关节疼痛的改善相关。需要进一步的研究来进一步了解CBD对AIMSS的影响以及哪些患者最有可能从CBD治疗中受益。试验注册www.clinicaltrials.gov: NCT04754399
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来源期刊
Cancer Medicine
Cancer Medicine ONCOLOGY-
CiteScore
5.50
自引率
2.50%
发文量
907
审稿时长
19 weeks
期刊介绍: Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.
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