Acupuncture therapy for vasomotor symptoms in breast cancer: Protocol for a prospective, multicenter, case registry study

Abstract

Introduction

Adjuvant endocrine therapy for breast cancer has advantages such as reducing the incidence of recurrence. However, adjuvant endocrine therapy may cause adverse vasomotor symptoms. Although randomized controlled trials (RCTs) have shown that acupuncture therapy is an effective treatment for vasomotor symptoms in patients with breast cancer, a practical real-world acupuncture regimen has yet to be established. Therefore, there is an urgent need for a case registry study that provides real-world evidence for the effectiveness of acupuncture therapy in treating vasomotor symptoms. This article presents the protocol for a case registry study that aims to provide an overview of the acupuncture therapy for managing vasomotor symptoms in patients with breast cancer.

Methods

The study cohort will comprise patients with breast cancer with vasomotor symptoms who are aged between 18 and 70 years and are undergoing adjuvant endocrine therapy. Patients will be recommended to receive acupuncture therapy, without excluding other treatments. The primary outcome is the patient-reported change in the hot flashes score. Electronic case report forms will be used to record patient demographic characteristics, information about interventions, and information about medical personnel from week 1 to 8, with a subsequent follow-up period of 24 weeks. At least 250 patients will be recruited from six medical hospitals. Adverse events will be monitored and recorded. An appropriate mixed model will be used to analyze the factors potentially influencing the effects of acupuncture therapy.

Discussion

This multicenter, prospective, observational, case registry study will bridge the gap between the clinical practices of acupuncture therapy and the evidence established through RCTs and systematic reviews. The findings will provide knowledge to better inform regulatory decision-making.

Conclusion

The findings of this case registry study will identify subgroups of patients with breast cancer that will benefit from acupuncture therapy for vasomotor symptoms.

Registration

This study was registered in the Chinese Clinical Trial Registry (ChiCTR2400081274)