RecruitingNot ApplicableNCT06642428

Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer

Sponsor

Jiuda Zhao

Enrollment

140 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Vitamin D Neoadjuvant Therapy Adverse Reaction Efficacy Chemotherapy

Summary

This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of 5.neoadjuvant chemotherapy or combined targeted therapy.
Life expectancy of at least 6 months. 7.No other uncontrolled benign diseases at the time of recruitment. 8.All patients must have complete clinical medical records. 9.Willingness to voluntarily sign an informed consent form.

Exclusion Criteria8

History of invasive breast cancer.
Prior systemic treatment for the treatment or prevention of breast cancer.
Known allergic reactions to vitamin D or calcium compounds.
Comorbidities that may affect vitamin D or calcium balance or bone health.
Vitamin D or calcium supplementation in the past 3 months.
Presence of other tumors.
Pregnant or lactating women.
Individuals who do not wish to participate in the study.

Interventions

DRUGNeoadjuvant therapy + vitamin D2

Before the start of treatment and every 3 weeks thereafter, participants will receive injections of vitamin D2 at a dosage of 10 mg until the completion of neoadjuvant therapy. They will undergo the standard neoadjuvant regimen, which includes the 10 mg injection of vitamin D2 per cycle during the therapy. The dosage of neoadjuvant drugs may be tailored based on the physician's clinical judgment.

DRUGNeoadjuvant therapy

Participants will receive the standard neoadjuvant regimen during each cycle of neoadjuvant therapy. The dosage of the neoadjuvant drugs may be tailored based on the physician's clinical judgment.