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Replacement of Vitamin D in Women with Breast Cancer Who Will Undergo Chemotherapy Before Surgery

Not Applicable
Recruiting
Conditions
Malignant neoplasms (tumors) of the breast
Registration Number
RBR-10k4gqdg
Lead Sponsor
niversidade Estadual Paulista - Unesp
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Women aged above 45 years with a recent histological diagnosis of breast cancer, eligible for neoadjuvant chemotherapy (presence of luminal tumors A or B with clinically positive armpit; luminal tumor B larger than three centimeters; triple negative tumor; tumor Human Epidermal growth factor Receptor-type 2 positive, pure or hybrid, stage III)

Exclusion Criteria

Vitamina d supplementation women with breast carcinoma in situ, previous history of other cancers, chronic kidney disease (creatinine upper 1.4 milligrams/deciliter), liver disease, alcohol or drug addiction will be excluded

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcome will be to assess the complete tumor pathological response rate of women with breast cancer undergoing vitamin D supplementation during neoadjuvant chemotherapy. The present study was based on previous research by Almeida-Filho (2017), who detected hypovitaminosis D in 66.1% of women at the time of breast cancer diagnosis and only 33.9% with sufficient values of vitamin D, in women attended at the mastology service of the Botucatu Medical School - São Paulo State University
Secondary Outcome Measures
NameTimeMethod
Secondary outcome will be to evaluate the complete tumor pathological response rate of women with breast cancer undergoing vitamin D supplementation during neoadjuvant chemotherapy according to age group; tumor staging and subtype; anthropometry (obesity and waist circumference); presence of metabolic syndrome; baseline serum values of vitamin D; and the vitamin D receptor polymorphism
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