Clinical trial · Observational
Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy
Early Breast Cancer, Endocrine Therapy Initiation, and Early Metabolic Health Changes: a Prospective Follow-up Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Breast Cancer | — | UNRESOLVED | — |
| Estrogen Receptor Positive Breast Cancer | — | UNRESOLVED | — |
| Metabolic Health | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Early breast cancer patients initiating endocrine therapy
- description
- Patients with estrogen receptor-positive breast cancer initiating adjuvant endocrine therapy (either tamoxifen or aromatase inhibitors).
Primary outcomes (9)
- measure
- Metabolic health changes
- timeFrame
- 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
- description
- A change (deterioration or improvement) in metabolic health compared to baseline. Defined by a change in at least one of the below mentioned parameters.
- measure
- Waist and hip circumference
- timeFrame
- 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
- description
- A change in waist- and hip circumference compared to baseline
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Invasive ER+ breast cancer * No diabetes treatment * Planned for initiation of any adjuvant endocrine therapy. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDNissen L, Busk Holm J, Borgquist S. Exploring the Impact of Initiating Endocrine Therapy on Metabolic Health in Early Breast Cancer: Protocol for the Prospective Follow-Up EMETA-Study. JMIR Res Protoc. 2026 Mar 25;15:e78589. doi: 10.2196/78589. PMID 41880605