RecruitingNot ApplicableNCT06642441

Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer

Sponsor

Jiuda Zhao

Enrollment

100 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Vitamin D Adverse Reaction Chemotherapy

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria9

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 Criteria8

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.

Interventions

DRUGChemotherapy + 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.

DRUGChemotherapy

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.