Actively Recruiting
Effect of Vitamin D Supplementation on Efficacy and Side Effects of Neoadjuvant Therapy in Breast Cancer Patients
Led by Jiuda Zhao · Updated on 2025-01-17
140
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of supplemental vitamin D on the effectiveness and side effects of neoadjuvant therapy in patients with breast cancer. This randomized controlled Phase III trial aims to compare outcomes such as response rates and adverse effects between patients receiving standard therapy with or without added vitamin D. The study focuses on patients whose breast cancer is confirmed and who have low vitamin D levels before starting treatment. Participants are randomly assigned to one of two groups. One group receives standard neoadjuvant therapy plus vitamin D2 injections of 10 mg every three weeks throughout their treatment cycles. The other group receives only the standard neoadjuvant therapy, with dosages adjusted by their physician as needed. Both groups undergo treatment cycles approximately every three weeks until completion. Throughout the study, blood samples and imaging are collected before treatment and after every two therapy cycles to assess response. Researchers measure key outcomes including the objective response rate, pathological complete response rate, disease control rate, and significant adverse effects related to therapy. Side effects are monitored from treatment start until 21 days after the last therapy cycle. The total study duration for each participant spans about 4 to 6 months, allowing thorough evaluation of treatment impact and safety.
CONDITIONS
Brief Title
Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years with ECOG performance status of 0-2
- Primary diagnosis of breast cancer confirmed by preoperative pathology
- Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L)
- No prior chemotherapy and planning 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
- Willing to voluntarily sign informed consent
You will not qualify if you...
- History of invasive breast cancer
- Prior systemic treatment for breast cancer
- Known allergies to vitamin D or calcium compounds
- Comorbidities affecting vitamin D or calcium balance or bone health
- Vitamin D or calcium supplementation within past 3 months
- Presence of other tumors
- Pregnant or lactating women
- Individuals unwilling to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 months
Participants receive standard neoadjuvant therapy with or without vitamin D2 supplementation every 3 weeks during each cycle of therapy. The dosage of neoadjuvant drugs may be tailored based on the physician's clinical judgment.
Visits every 3 weeks corresponding with each treatment cycle
Duration - Up to 3 weeks after last treatment cycle
Participants are monitored for side effects related to neoadjuvant therapy from the start of treatment up to 21 days after the last cycle.
Approximately 1 follow-up visit after treatment completion
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
Research Team
J
Jiuda Zhao
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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