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

Vitamin D Supplementation in Women with Breast Cancer Undergoing Neoadjuvant Chemotherapy: Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10k4gqdg
Enrollment
Unknown
Registered
2022-07-04
Start date
2021-06-22
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Malignant neoplasms (tumors) of the breast

Interventions

Experimental group: 30 women diagnosed with breast cancer and indication for neoadjuvant chemotherapy treatment will receive vitamin D 1000IU, two tablets, once a day orally for six months. Control gr
D04.210.500.247.222.159

Sponsors

Universidade Estadual Paulista - Unesp
Lead Sponsor
Universidade Estadual Paulista - Unesp
Collaborator

Eligibility

Sex/Gender
Female
Age
45 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Brazil

Contacts

Public ContactEliana Nahas

Universidade Estadual Paulista - Unesp

eliana.nahas@unesp.br+55-14-38801377

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026