Clinical Takeaway
Topical cannabis balms were tested in women with breast cancer experiencing joint pain and stiffness caused by aromatase inhibitor therapy. The trial evaluated whether this approach was practical and well-tolerated, with early efficacy data suggesting a potential role for cannabinoids in managing AIMSS. Findings support further investigation of topical cannabis as a non-systemic option for patients struggling with this common and treatment-limiting side effect.
#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 investigating a potential non-pharmacologic intervention for AIMSS, a common adverse effect that compromises treatment adherence in approximately two-thirds of women receiving AI therapy for hormone receptor-positive breast cancer. If topical cannabis demonstrates feasibility and tolerability, it could offer a mechanism to improve AI compliance without systemic drug interactions or the adverse effects associated with alternative analgesics. Given that inadequate AI adherence directly impacts oncologic outcomes, establishing effective symptom management strategies has direct implications for breast cancer survival and recurrence rates.
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 roughly two-thirds of women on aromatase inhibitors and substantially impairs medication adherence, yet treatment options remain limited. Topical cannabis balms are mechanistically plausible given cannabinoids’ anti-inflammatory properties, and the open-label design appropriately fits an early-stage feasibility study. However, the absence of a placebo control and reliance on patient-reported outcomes mean we cannot yet distinguish true drug effect from expectancy effects, which carry particular weight in pain symptomatology; additionally, heterogeneous balm formulations, variable cannabinoid content, and lack of standardization across cannabis products remain significant confounders in translating findings to clinical practice. For providers managing women struggling with AI adherence due to joint symptoms, topical cannabinoid products may warrant discussion as part of a multimodal approach—particularly when conventional analgesics or physical therapy have proven insufficient—though patients should understand the current evidence is preliminary and clinicians should