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 Cannabinoid Res. 2026 Feb;11(1):30-35. doi: 10.1177/25785125251398286. Epub 2025 Dec 29.

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.

Keywords: aromatase inhibitor; cancer; cannabis; marijuana; musculoskeletal symptoms; topical.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Aromatase Inhibitors* / adverse effects
  • Breast Neoplasms / drug therapy
  • Cannabidiol* / administration & dosage
  • Cannabidiol* / adverse effects
  • Cannabidiol* / therapeutic use
  • Dronabinol* / administration & dosage
  • Dronabinol* / adverse effects
  • Dronabinol* / therapeutic use
  • Feasibility Studies
  • Female
  • Humans
  • Medical Marijuana* / administration & dosage
  • Medical Marijuana* / adverse effects
  • Medical Marijuana* / therapeutic use
  • Middle Aged
  • Musculoskeletal Diseases* / chemically induced
  • Musculoskeletal Diseases* / drug therapy

Substances

  • Aromatase Inhibitors
  • Cannabidiol
  • Dronabinol
  • Medical Marijuana