Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer

Launched by JIUDA ZHAO · Oct 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether taking vitamin D supplements can help improve the effectiveness and reduce the side effects of neoadjuvant therapy for patients with breast cancer. Neoadjuvant therapy is a treatment given before surgery to shrink tumors, and this study aims to see if vitamin D can make this treatment work better for patients who have low levels of vitamin D in their blood.

To be eligible for the trial, participants need to be between 18 and 80 years old, have a confirmed diagnosis of breast cancer, and have low vitamin D levels (specifically, less than 20 ng/ml). They should also be planning to undergo at least four cycles of neoadjuvant chemotherapy and have a life expectancy of at least six months. Participants will be randomly assigned to receive either vitamin D supplements or a placebo (a substance with no active ingredients) during their treatment. This study is currently recruiting patients, and all participants will need to provide informed consent before joining. If you or someone you know meets these criteria and is interested, it could be a valuable opportunity to contribute to important breast cancer research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• • 2. Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
• • 3. Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
• • 4. Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of 5.neoadjuvant chemotherapy or combined targeted therapy.
• • 6.Life expectancy of at least 6 months. 7.No other uncontrolled benign diseases at the time of recruitment. 8.All patients must have complete clinical medical records. 9.Willingness to voluntarily sign an informed consent form.
• Exclusion Criteria:
• • 1. History of invasive breast cancer.
• • 2. Prior systemic treatment for the treatment or prevention of breast cancer.
• • 3. Known allergic reactions to vitamin D or calcium compounds.
• • 4. Comorbidities that may affect vitamin D or calcium balance or bone health.
• • 5. Vitamin D or calcium supplementation in the past 3 months.
• • 6. Presence of other tumors.
• • 7. Pregnant or lactating women.
• • 8. Individuals who do not wish to participate in the study.