Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation
This trial is active, not recruiting.
|Conditions||breast neoplasms, postmenopausal disorder|
|Sponsor||University of Sao Paulo General Hospital|
|Collaborator||Instituto Brasileiro de Controle do Cancer|
|Start date||July 2007|
|End date||June 2013|
|Trial size||60 participants|
|Trial identifier||NCT00926315, CAPPesq 0018/09, CAPPesq 626/06, FAPESP 07/04799-2, FMUSPIBCCVD2009, IBCC 108/2006/07|
The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients.
|Intervention model||single group assignment|
calcitriol supplementation (0.25 mcg 2x/d)
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile
time frame: 30 days
Follow-up for 5 years
time frame: 5 years
Female participants from 40 years up to 70 years old.
Inclusion Criteria: - Postmenopausal women - Invasive breast carcinoma - Clinical conditions for breast surgery - No previous neoadjuvant treatment for breast cancer - Agreement to take part in the study and sign the informed consent Exclusion Criteria: - History of hypercalcemia or nephrolithiasis - Current use of corticosteroids, vitamin D supplementation, HRT - Previous chemotherapy, hormonotherapy or radiotherapy - Parathyroid disease - Absence of clinical condition to receive supplementation
|Official title||Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients|
|Principal investigator||Eduardo Carneiro de Lyra, MD, PhD|
|Description||Women affected by breast cancer present lower 1,25(OH)2D3 or 25(OH)D3 serum levels than unaffected ones. Calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. Vitamin D has antiproliferative effects in breast cancer cell lines and breast cancer xenografts. Post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). Tumor dimension and proliferation rate (as determined by Ki67 expression), 25(OH)D3 and/or 1,25(OH)2D3 serum concentration, will be evaluated before and after calcitriol supplementation. Tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile.|
Call for more information