Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy
Launched by AARHUS UNIVERSITY HOSPITAL · Oct 1, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to understand how starting antihormone therapy affects the metabolic health of patients with early breast cancer. Specifically, the researchers want to see if there are early changes in things like weight, blood pressure, and blood sugar levels after patients begin treatment. They believe that within the first three months of starting this therapy, there may be a decline in metabolic health, even as hormone levels decrease. The study will include about 112 patients at Aarhus University Hospital over six months, starting in the autumn of 2024.
To participate, you need to be at least 18 years old, have a specific type of breast cancer (called estrogen receptor-positive or ER+), and not be receiving treatment for diabetes. If you join, you will have two check-ups: one on the day you start your therapy and another three months later, during which your height, weight, waist and hip sizes, and blood samples will be taken to monitor any changes. It’s important to note that if you are pregnant, breastfeeding, or have certain personal circumstances that might make it difficult to follow the study, you will not be eligible to participate.
Gender
ALL
Eligibility criteria
- 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.
About Aarhus University Hospital
Aarhus University Hospital is a leading research institution in Denmark, dedicated to advancing medical science and improving patient care through innovative clinical trials. As a key sponsor of clinical research, the hospital integrates cutting-edge technology and multidisciplinary expertise to conduct studies that address critical health challenges. With a commitment to ethical standards and patient safety, Aarhus University Hospital collaborates with a diverse network of academic and industry partners, ensuring that its research initiatives contribute to the global body of medical knowledge and enhance treatment options for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aarhus N, Central Denmark Region, Denmark
Patients applied
Trial Officials
Signe Borgquist, Clinical Chair Professor, Ph.D
Principal Investigator
Aarhus University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported