Actively Recruiting
Effect of Vitamin D Supplementation on Side Effects Following Adjuvant Chemotherapy for Breast Cancer
Led by Jiuda Zhao · Updated on 2025-01-17
100
Participants Needed
2
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how vitamin D supplementation affects the side effects of chemotherapy in patients with breast cancer. This randomized controlled Phase III trial focuses on women and men aged 18 to 80 years who have been diagnosed with breast cancer and are scheduled to receive adjuvant chemotherapy. The goal is to understand if adding vitamin D can influence the occurrence of severe treatment side effects during chemotherapy. Participants are divided into two groups. Both groups receive standard adjuvant chemotherapy, with the dosage tailored by their doctors as needed. One group also receives vitamin D2 injections of 10 mg before treatment and every three weeks throughout the chemotherapy cycles until completion. Blood samples and imaging tests are collected before starting chemotherapy and after every two cycles to closely monitor changes and reactions. During the study, participants will be regularly assessed for side effects, especially those of grade III or higher, linked to treatment. Researchers will gather detailed information through blood tests, imaging results, and clinical evaluations throughout the chemotherapy period. The main outcome measured is the incidence and proportion of treatment-related adverse events over 4 to 6 months. Safety, treatment effects, and any adverse events will be thoroughly reviewed to understand the impact of vitamin D supplementation.
CONDITIONS
Official 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 breast cancer diagnosis confirmed by preoperative pathology
- Serum 25(OH)D levels below 20 ng/ml (50 nmol/L)
- No prior chemotherapy and planning to undergo at least 4 cycles of adjuvant chemotherapy
- Receiving adjuvant chemotherapy or combined targeted therapy
- Life expectancy of at least 6 months
- No uncontrolled benign diseases at recruitment
- Complete clinical medical records available
- Willing to sign informed consent voluntarily
You will not qualify if you...
- History of invasive breast cancer
- Previous systemic treatment for breast cancer prevention or treatment
- Allergic reactions to vitamin D or calcium compounds
- Comorbidities affecting vitamin D or calcium balance or bone health
- Vitamin D or calcium supplementation within the past 3 months
- Presence of other tumors
- Pregnancy or lactation
- Unwillingness to participate in the study
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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
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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