Actively Recruiting
Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
Led by Jiuda Zhao · Updated on 2025-01-17
100
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of vitamin D supplementation on side effects experienced during adjuvant chemotherapy in patients with breast cancer. This Phase III randomized controlled trial focuses on whether adding vitamin D2 affects the occurrence of severe side effects during chemotherapy treatment. Both groups also receive standard chemotherapy, and the study aims to thoroughly assess adverse events related to the treatment. Participants are randomly assigned to one of two groups: one group receives standard chemotherapy along with vitamin D2 injections, administered before treatment and every three weeks during chemotherapy cycles; the other group receives only the standard chemotherapy regimen. The dosage of chemotherapy drugs may be adjusted based on the doctor's clinical judgment. Blood samples and imaging are collected before starting chemotherapy and after every two cycles to monitor effects. During the study, researchers will document and analyze the incidence of treatment-related adverse events of grade III or higher, as well as side effects using health status and fatigue scales from the start of chemotherapy to 21 days after the last cycle. The total participation includes multiple chemotherapy cycles over approximately 4 to 6 months, with ongoing monitoring of safety and treatment impact throughout this period.
CONDITIONS
Brief Title
Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years with an ECOG performance status of 0-2
- Primary diagnosis of breast cancer confirmed by pathological examination
- Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L)
- No prior chemotherapy and planned for at least 4 cycles of adjuvant chemotherapy or combined targeted therapy
- Life expectancy of at least 6 months
- No uncontrolled benign diseases at recruitment
- Complete clinical medical records
- Willingness to sign informed consent form voluntarily
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 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 unwilling to participate in the study
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 adjuvant chemotherapy cycles. One group also receives vitamin D2 injections before the start and every 3 weeks during chemotherapy until treatment completion. Blood samples and imaging are collected before treatment and after every two chemotherapy cycles.
Visits every 3 weeks during chemotherapy cycles
Duration - Approximately 3 weeks
Participants are monitored for side effects and adverse events for 21 days after the last chemotherapy cycle.
1 follow-up visit
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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