Exploring the Impact of Initiating Endocrine Therapy on Metabolic Health in Early Breast Cancer: Protocol for the Prospective Follow-Up EMETA-Study
Abstract
Background: Adjuvant endocrine therapy is a cornerstone in managing estrogen receptor-positive early breast cancer but may adversely affect metabolic health, including weight gain, insulin resistance, and dyslipidemia. These changes increase the risk of cardiovascular disease and may influence breast cancer outcomes. However, the timing and magnitude of early metabolic changes following endocrine therapy initiation remain poorly characterized. Conventional definitions such as metabolic syndrome rely on dichotomous thresholds and may lack sensitivity to detect early treatment-related metabolic changes, highlighting the need for refined assessment approaches.
Objective: This prospective follow-up study aims to investigate early metabolic effects of initiating adjuvant endocrine therapy in women with estrogen receptor-positive early breast cancer and to compare conventional and expanded approaches to metabolic health classification.
Methods: This single-center, prospective observational study was conducted at Aarhus University Hospital, Denmark. Women aged≥18 years with early-stage estrogen receptor-positive breast cancer initiating adjuvant endocrine therapy and without pre-existing diabetes were eligible. Metabolic health was assessed at baseline and after 3 months using biometric measurements (weight, waist and hip circumference, waist-to-hip ratio, and blood pressure) and non-fasting blood samples (plasma glucose; hemoglobin A1c, (HbA1c); lipid profile; and estradiol). The…
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Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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