Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy

Condition(s) studied

Study summary

This clinical trial aims to investigate early metabolic health changes in early breast cancer patients that initiate antihormone therapy. Furthermore, how these changes are affected by estrogen level, treatment type, and patient characteristics. The hypothesis is, that initiation of antihormone therapy for early breast cancer patients is associated with an early deterioration in metabolic health after 3 months. This includes increased BMI (Body Mass Index), waist- and hip circumference, blood pressure, blood sugars, and lipids compared to when the patients initiate antihormone therapy. Concurrently, estradiol levels are expected to decrease. An estimated 112 patients initiating antihormone therapy at the Dept. of Oncology, Aarhus University Hospital (AUH) will be included in the study over 6 months from autumn 2024. Patients will have a metabolic screening on the day of initiating antihormone therapy and at 3-month antihormone treatment follow-up. The two metabolic screenings each consists of biometric measurements and a blood sample.

Eligibility

Primary outcome measure(s)

• Metabolic health changes — 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
  A change (deterioration or improvement) in metabolic health compared to baseline. Defined by a change in at least one of the below mentioned parameters.
• Waist and hip circumference — 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
  A change in waist- and hip circumference compared to baseline
• Blood pressure — 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
  A change in blood pressure compared to baseline
• HbA1c — 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
  A change in circulating levels of glycated hemoglobin (HbA1c)
• Cholestrerol — 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
  A change in blood cholesterol compared to baseline
• Triglycerides — 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
  A change in triglycerides compared to baseline
• LDL — 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
  A change in low-density lipoprotein (LDL) compared to baseline.
• HDL — 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
  A change in and high-density lipoprotein (HDL) compared to baseline
• Body Mass Index — 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
  A change in Body Mass Index (Height and weight combined, kg/m2)

Trial sites (1)

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