Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
NCT06642428 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2025-01-17
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.
Conditions
- Vitamin D
- Neoadjuvant Therapy
- Breast Cancer
- Adverse Reaction
- Efficacy
- Chemotherapy
Interventions
- DRUG
-
Neoadjuvant 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.
- DRUG
-
Neoadjuvant 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.
Sponsors & Collaborators
-
Jiuda Zhao
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-18
- Primary Completion
- 2026-01-31
- Completion
- 2026-04-30
Countries
- China
Study Locations
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