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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital

About this trial

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 criteria

Qualifiers

Age ≥18 years

Invasive ER+ breast cancer

No diabetes treatment

Planned for initiation of any adjuvant endocrine therapy.

Disqualifiers

Pregnancy or lactation,

Psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

112 Participants
are grouped into 1 trial group

Sponsors and collaborators

Aarhus University Hospital

Lead sponsor

Danish Cancer Society

Collaborator