About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Postmenopausal
Breast cancer stage I-III
Eligible to receive (neo-)adjuvant chemotherapy/other antineoplastic treatment
Disqualifiers
Prior malignancy
Metabolic disease (diabetes mellitus etc)
Trial population
Postmenopausal women age 50-70 years diagnosed with breast cancer stage I-III eligible to receive (neo-)adjuvant chemotherapy or other adjuvant antineoplastic treatments including trastuzumab and CKK4-6 inhibitors, AI and bisphosphonate. Exclusion criteria include prior malignancy, preexisting T2D or other metabolic disease. The women will be recruited via the Department of Oncology at Rigshospitalet, Denmark.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Bone Mineral Density
Change in bone mineral density
Metabolic syndrome
Change in number of patients with the metabolic syndrome
Secondary outcomes
Bone fracture
Change in number of fractures
Insulin resistance
Change in insulin resistance
Glucose
Change in blood glucose
Sponsors and contacts
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