Clinical Takeaway
Topical cannabis balms were tested in a randomized, open-label trial among postmenopausal women with hormone receptor-positive breast cancer who developed musculoskeletal pain and joint stiffness from aromatase inhibitor therapy. The trial evaluated whether this approach was feasible and well-tolerated, with preliminary efficacy data collected as a secondary aim. Results provide early-stage clinical evidence on the potential role of topical cannabinoids in managing a common side effect that frequently causes patients to discontinue a proven cancer treatment.
#16 A Randomized, Open-Label Trial to Assess Feasibility and Tolerability of Topical Cannabis Balms for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS).
Citation: Zylla Dylan et al.. A Randomized, Open-Label Trial to Assess Feasibility and Tolerability of Topical Cannabis Balms for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS).. Cannabis and cannabinoid research. 2026. PMID: 41467893.
Design: 5 Journal: 1 N: 0 Recency: 3 Pop: 2 Human: 1 Risk: -2
This study addresses a significant clinical gap by evaluating a potential treatment for AIMSS, which affects approximately two-thirds of patients on aromatase inhibitors and contributes to therapy non-adherence in breast cancer survivors. If topical cannabis balms demonstrate tolerability and efficacy, they could offer an alternative or adjunctive option for managing AIMSS-related pain and inflammation without the systemic side effects associated with oral medications or the adherence concerns that threaten cancer treatment outcomes.
Quality Gate Alerts:
- Preclinical only
Methodological Considerations:
- Open-label design — placebo effect not excluded
Abstract: INTRODUCTION: Aromatase inhibitors (AIs) are commonly used for postmenopausal women with hormone receptor-positive breast cancer. Nearly two-thirds of women on AIs have arthralgias, joint stiffness, and/or bone pains referred to as aromatase inhibitor-induced musculoskeletal syndrome (AIMSS), leading to poor adherence. Preclinical and clinical data suggest topical cannabinoids can reduce inflammation in arthritis. MATERIALS AND METHODS: We conducted a randomized trial assessing feasibility, tolerability, and preliminary efficacy of topical cannabis for women with stage 1-3 breast cancer experiencing AIMSS. Women were randomized 1:1 to cannabidiol (CBD) vs. delta-9-tetrahydrocannabinol (THC) balms. The balm was applied three times daily to hands for 2 weeks, followed by a 2-week extension with the balm of their choice. Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affectations of the Hands (M-SACRAH), brief pain inventory, and skin toxicity measures were captured weekly. RESULTS: A total of 21 women completed the study over 14 months. The mean age was 54, 86% White, 43% received adjuvant chemotherapy, and 48% reported no lifetime cannabis use. Compliance was high, with 71% continuing an additional 2 weeks and 86% of weekly surveys completed. We found 86% of participants reported improvement in M-SACRAH from baseline to week 2 with a higher percentage of the THC balm group reporting a >50% improvement (50% vs. 18%). Minor skin irritation was reported by 24%, and one patient discontinued balm due to “greasy” texture. CONCLUSIONS: Conducting a randomized trial of topical cannabis using state-approved dispensaries is feasible. Both THC and CBD balms are well tolerated. Placebo-controlled trials are needed to determine if balms can reduce AIMSS severity in breast cancer survivors.
💊 This feasibility trial addresses a genuine clinical gap—AIMSS affects adherence to potentially life-saving endocrine therapy in a substantial proportion of breast cancer survivors—and topical cannabinoids offer a theoretically plausible anti-inflammatory approach worth exploring. However, the open-label design without blinded control creates significant bias risk, particularly for subjective pain outcomes, and the lack of pharmacokinetic data means we cannot determine whether topical application achieves meaningful systemic or local cannabinoid concentrations in affected joints. The study’s value lies mainly in establishing tolerability and recruitment feasibility rather than efficacy, and we should interpret any symptom improvements cautiously until randomized, placebo-controlled data emerge. For now, practitioners might discuss topical cannabis as a low-risk adjunctive option for patients with refractory AIMSS who are motivated to optimize AI adherence, while remaining transparent about the limited evidence base and encouraging concurrent evidence-based approaches such as exercise, NSAIDs, or rheumat