Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
Recruiting · NCT06642428 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiuda Zhao
View the official record on ClinicalTrials.gov →Interventions studied
Neoadjuvant therapyNeoadjuvant therapy + vitamin D2
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
2 locations listed.
- Qinghai University Affiliated Hospital - Xining, Qinghai, China
- Qinghai University Affiliated Hospital - Xining, Qinghai, China