Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemotherapy + vitamin D2, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Vitamin D, Chemotherapy, Breast Cancer, Adverse Reaction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This randomized controlled Phase III trial was designed to evaluate the effect of vitamin D supplementation (VD) on chemotherapy side effects following adjuvant chemotherapy in breast cancer
Detailed description
This is a parallel group, open-label randomized controlled trial to investigate the occurrence of side effects of vitamin D supplementation (VD) in adjuvant chemotherapy in patients with breast cancer. Both groups will receive standard adjuvant chemotherapy on day 1 and each subsequent cycle. In addition, vitamin D2 will be given randomly to both groups. Blood samples and imaging results were collected and analyzed before initiation of adjuvant chemotherapy and after every two cycles. The primary outcome to be documented was associated grade III or higher adverse events during adjuvant chemotherapy. Primary and secondary study findings and adverse events will be thoroughly evaluated.
Interventions
- Drug Chemotherapy + vitamin D2
Before the start of treatment and every 3 weeks thereafter, participants will receive a 10 mg dose of vitamin D2 injection until adjuvant chemotherapy is completed. They will receive a standard adjuvant chemotherapy regimen, which includes 10 mg of vitamin D2 injections per cycle during treatment. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor. - Drug Chemotherapy
Participants will receive a standard adjuvant chemotherapy treatment regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.
Primary outcome measures
- Incidence and proportion of treatment-related adverse events [Time frame: 4-6months]
Secondary outcome measures (3)
- Evaluation of side effects associated with adjuvant therapy (CTCAE v5.0) [Time frame: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.]
- Assessment of side effects associated with adjuvant therapy (EQ-5D Health Status Scale) [Time frame: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.]
- Assessment of side effects associated with adjuvant therapy (Abbreviated Fatigue Scale) [Time frame: From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.]
Eligibility criteria
Inclusion criteria
- Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
- Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
- Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of
- Patients with adjuvant chemotherapy or combined targeted therapy.
- Life expectancy of at least 6 months.
- No other uncontrolled benign diseases at the time of recruitment.
- All patients must have complete clinical medical records.
- Willingness to voluntarily sign an informed consent form.
Exclusion criteria
- History of invasive breast cancer.
- Prior systemic treatment for the treatment or prevention of breast cancer.
- Known allergic reactions to vitamin D or calcium compounds.
- Comorbidities that may affect 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 who do not wish to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Qinghai University Affiliated Hospital — Xining
- Qinghai University Affiliated Hospital — Xining
Identifiers
NCT: NCT06642441 · AHQU-2024004