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A Prospective, randomized , placebo, controlled trial ( double blinded) to assess the potential role of vitamin D treatment in breast cancer patients

A Prospective, randomized , placebo, controlled trial ( double blinded) to assess the potential role of vitamin D treatment in breast cancer patients - Potential role of Vitamin D treatment in Breast Cancer

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34378
Enrollment
110
Registered
2010-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer/ breast carcinoma

Interventions

Intervention: 1. Vitamin D supplementation, 40.000 IU/day in the intervention group and placebo in the control group, both 55 patients each. Supplementation starts after breast cancer diagnosis is

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: primary operable invasive breast cancer

Exclusion criteria

Exclusion criteria: Previously clinically detected nefrolithiasis (on diagnostic imaging techniques). Previously clinically detected cholelithiasis (on diagnostic imaging techniques). History of sarcoidosis. History of recurrent urolithiasis. Already taking Vitamin D (colecalciferol) supplement >400 IU/day. Calcium-lowering therapy within 2 weeks before study entry. Previously documented impaired renal function.

Design outcomes

Primary

MeasureTime frame
1. 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

MeasureTime frame
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. o Immunohistochemical markers to be studied are * Caspase 3 (apoptosis marker) * Vitamin D receptors (responsiveness marker) * HER 2Neu-, estrogen- and progesterone-receptor status (tumormarkers) 2. To study changes in serum calcium and vitamin D levels between day 1 and day of surgery 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). 4. Reporting any eventual adverse effects.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)