Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06642428

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

Led by Jiuda Zhao · Updated on 2025-01-17

140

Participants Needed

2

Research Sites

79 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years with ECOG performance status 0-2
  • Primary breast cancer diagnosis confirmed by preoperative pathology
  • Serum 25(OH)D vitamin D levels below 20 ng/ml (50 nmol/L)
  • No prior chemotherapy and planned to receive at least 4 cycles of neoadjuvant chemotherapy or combined targeted therapy
  • Life expectancy of at least 6 months
  • No uncontrolled benign diseases at recruitment
  • Complete clinical medical records available
  • Willingness to sign informed consent voluntarily
Not Eligible

You will not qualify if you...

  • History of invasive breast cancer
  • Prior systemic treatment for breast cancer
  • Known allergy to vitamin D or calcium compounds
  • Comorbidities affecting vitamin D, calcium balance, or bone health
  • Vitamin D or calcium supplements taken in the past 3 months
  • Presence of other tumors
  • Pregnant or lactating women
  • Unwillingness to participate in the study

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Qinghai University Affiliated Hospital

Xining, Qinghai, China, 810000

Not Yet Recruiting

2

Qinghai University Affiliated Hospital

Xining, Qinghai, China, 810000

Actively Recruiting

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Research Team

J

Jiuda Zhao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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