Potential role of vitamin D treatment in breast cancer.
- Conditions
- Vitamin D, breast cancer, apoptosis, proliferation
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
1. Primary operable invasive breast cancer;
2. Women;
Exclusion Criteria
Primary:
1. Inability to comply with a study protocol (e.g. abuse of alcohol, drugs, psychotic states);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the influence of vitamin D on immunohistochemical marker Ki 67 (proliferation marker) in breast cancer. This marker will be defined in the biopsy specimen and in the tumour resection specimen. The mean difference between these two marker values will be examined between the intervention and the control group.
- Secondary Outcome Measures
Name Time Method 1. To study the influence of vitamin D on immunohistochemical markers in biopsy specimen and tumour resection specimen in breast cancer. These markers will be defined in the biopsy specimen and in the tumour resection specimen. Immunohistochemical markers to be studied are:<br /><br>A. Caspase 3 (apoptosis marker);<br /><br>B. Vitamin D receptors (responsiveness marker);<br /><br>C. HER 2Neu-, estrogen- and progesterone-receptor status (tumormarkers).<br /><br>2. To study changes in serum calcium and vitamin D levels between day of diagnosis and day of surgery;<br /><br>3. Correlation of initial (=before treatment with vitamin D) serum vitamin D levels with clinicopathological parameters of breast cancer (tumour size, nodal status, grade, estrogen and progesterone receptor status, HER2 status);<br /><br>4. Reporting any eventual adverse effects.