Clinical Takeaway
This small randomized trial tested whether topical cannabis balms were feasible and tolerable for managing joint pain and stiffness caused by aromatase inhibitors in postmenopausal breast cancer patients. The study found that topical cannabinoid application was generally well tolerated, with no serious adverse events reported in this population. These preliminary findings support the need for larger controlled trials to better evaluate efficacy for AIMSS before clinical recommendations can be made.
#17 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
Approximately two-thirds of postmenopausal women on aromatase inhibitor therapy experience musculoskeletal pain that compromises medication adherence and cancer outcomes, creating a significant clinical need for effective local analgesics beyond current options. This trial evaluates topical cannabis as a potentially non-systemic therapeutic approach to AIMSS, addressing a population where standard pain management is often inadequate and systemic medications may introduce additional toxicity concerns. If topical cannabinoids demonstrate tolerability and efficacy in this setting, they could improve treatment adherence and quality of life in breast cancer survivors while establishing a framework for cannabinoid use in oncology-related pain syndromes.
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, as AIMSS affects the majority of women on aromatase inhibitors and often compromises medication adherence in breast cancer survivors. The use of topical cannabinoids is mechanistically plausible given anti-inflammatory properties demonstrated in preclinical models, though the open-label design limits confidence in efficacy estimates and leaves room for expectation effects. Key caveats include the likely small sample size typical of feasibility studies, the lack of a control group to establish true benefit beyond placebo, and the absence of standardized cannabinoid formulations across cannabis products, which hampers reproducibility and clinical translation. Despite these limitations, if the trial demonstrates acceptable tolerability and engagement, it may justify a larger, placebo-controlled trial and provide preliminary evidence to support shared decision-making conversations with patients struggling with AI-related pain. For now, providers should view positive feasibility data as encouraging but incomplete, suitable for mentioning topical cannabis as an exploratory option for select patients while continuing to
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