Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer
Recruiting · NCT03784651 · Observational (researchers observe without assigning treatment) · Lead sponsor: Rigshospitalet, Denmark
View the official record on ClinicalTrials.gov →What this trial is about
Breast cancer is the most common cancer type in European women. Patients treated for early non-metastatic breast cancer comprise a growing group of survivors due to early diagnosis and improved treatment. Many of these survivors experience adverse effects such as decreased bone mineral density, derangement of metabolic markers (fat, glucose, insulin) and increased blood pressure. Increasing risk of bone fracture and cardiometabolic disease (eg. diabetes mellitus type 2). The purpose of this study is to identify mechanisms behind cardiometabolic changes that may be connected to the (neo-)adjuvant treatment. On top of this we hope to indentify potential biological markers that can help prevent development of metabolic disease. We will be recruiting 120 post-menopausal women age 50-70 with early breast cancer and 1-2 times a year for 5 years examine bone mineral density, body composition, glucose and fat metabolism and nerve damage. A questionnaire will be used to collect information on diet, physical activity and quality of life. Derudover anvendes spørgeskemaer til at indsamle information vedrørende. This new knowledge will help clinicians start adequate preventive measures to help patients avoid cardiometabolic disease secondary to cancer treatment.
Who can take part
Inclusion criteria
- Postmenopausal
- Breast cancer stage I-III
- Eligible to receive (neo-)adjuvant chemotherapy/other antineoplastic treatment
Exclusion criteria
- Prior malignancy
- Metabolic disease (diabetes mellitus etc)
Where it is running
1 location listed.
- Rigshospitalet - Copenhagen, Danmark, Denmark