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
This trial does not accept healthy volunteersQualifiers
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 population
Early breast cancer patients consulted at Dept. of Oncology Aarhus University Hospital from autumn 2024 and 6 months ahead regarding adjuvant treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
112 Participants
are grouped into 1 trial groupGroup A: Early breast cancer patients initiating endocrine therapy
Trial outcomes
Primary outcomes
1
Metabolic health changes
A change (deterioration or improvement) in metabolic health compared to baseline. Defined by a change in at least one of the below mentioned parameters.
Time frame
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)2
Waist and hip circumference
A change in waist- and hip circumference compared to baseline
Time frame
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)3
Blood pressure
A change in blood pressure compared to baseline
Time frame
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)4
HbA1c
A change in circulating levels of glycated hemoglobin (HbA1c)
Time frame
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)Secondary outcomes
1
Estrogen level
Changes in circulating estrogen compared to baseline
Time frame
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aarhus University Hospital
Lead sponsor
Danish Cancer Society
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: