Impact of Vitamin D on Neoadjuvant Therapy for Breast Cancer

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

This study is testing whether adding vitamin D to standard treatment helps breast cancer patients feel better and have better results from their therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Affiliated Hospital of Qinghai University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Xining, Qinghai and 1 other locations)
• Trial ID: NCT06642428 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to evaluate how supplemental vitamin D affects the efficacy and side effects of neoadjuvant therapy in breast cancer patients. Participants will be randomly assigned to receive either standard neoadjuvant therapy alone or with added vitamin D2. Blood samples and imaging will be collected to assess outcomes such as pathological complete response and adverse effects after each treatment cycle. The study will provide insights into the potential benefits of vitamin D supplementation in improving treatment outcomes and reducing side effects.

Who should consider this trial

Good fit: Ideal candidates are breast cancer patients aged 18-80 with low serum vitamin D levels who have not previously undergone chemotherapy.

Not a fit: Patients with a history of invasive breast cancer or those who have received prior systemic treatment for breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the effectiveness of neoadjuvant therapy and minimize adverse effects for breast cancer patients.

How similar studies have performed: While the role of vitamin D in cancer treatment is being explored, this specific approach of combining it with neoadjuvant therapy is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Xining, Qinghai and 1 other locations

• Qinghai University Affiliated Hospital — Xining, Qinghai, China (Not_yet_recruiting)
• Qinghai University Affiliated Hospital — Xining, Qinghai, China (Recruiting)

Study contacts

• Study coordinator: Jiuda Zhao

Conditions Vitamin D; Neoadjuvant Therapy; Breast Cancer; Adverse Reaction; Efficacy; Chemotherapy