Self-acupressure for patients with breast cancer experiencing aromatase inhibitor-associated musculoskeletal symptoms: Protocol for the AcuAIM randomized pilot trial

PLoS One. 2025 Jan 22;20(1):e0311044. doi: 10.1371/journal.pone.0311044. eCollection 2025.

Abstract

Background: Aromatase inhibitors (AI) reduce hormone receptor-positive breast cancer recurrence risk by about 50%. However, half of AI-treated postmenopausal women report new or worsened musculoskeletal symptoms (AIMSS), and 20% discontinue therapy prematurely. Acupuncture is effective for reducing symptoms, but many women are not able to access acupuncture therapy. We hypothesize that self-administered acupressure will reduce AIMSS.

Materials and methods: Postmenopausal women who have been receiving treatment with an AI for more than 3 weeks but less than 2 years, and who report new or worsened joint pain or myalgias since starting AI therapy with worst pain of at least 4 out of 10 on a numerical rating scale, are eligible. Fifty participants will be enrolled and randomized 1:1 to treatment with true or sham acupressure for 12 weeks. Participants will self-apply pressure for 3 minutes to each of the 9 acupoints daily. All participants will complete a pain assessment weekly, and a battery of symptom questionnaires every 6 weeks. Optional stool samples will be collected after 0 and 12 weeks of acupressure to examine changes in the gut microbiome. The primary endpoint is change in worst pain on the Brief Pain Inventory-Short Form with 12 weeks of the acupressure intervention, evaluated with generalized estimating equations.

Conclusion: Determination that self-administered acupressure reduces AIMSS in this randomized phase 2 pilot trial will lead to a larger randomized phase 3 clinical trial to confirm the efficacy of self-acupressure. Reduction of AI-related arthralgias may improve persistence with breast cancer therapy, breast cancer outcomes, and quality of life for AI-treated patients.

Trial registration: Clinicaltrials.gov NCT06228768.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial Protocol

MeSH terms

  • Acupressure* / methods
  • Aromatase Inhibitors* / adverse effects
  • Aromatase Inhibitors* / therapeutic use
  • Arthralgia / chemically induced
  • Arthralgia / etiology
  • Arthralgia / therapy
  • Breast Neoplasms* / drug therapy
  • Female
  • Humans
  • Middle Aged
  • Pilot Projects
  • Postmenopause
  • Quality of Life

Substances

  • Aromatase Inhibitors

Associated data

  • ClinicalTrials.gov/NCT06228768