RecruitingNot ApplicableNCT06642428

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

Sponsor

Jiuda Zhao

Enrollment

140 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Vitamin D Neoadjuvant Therapy Adverse Reaction Efficacy Chemotherapy

Summary

This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether taking vitamin D supplements during neoadjuvant (pre-surgery) chemotherapy for breast cancer can improve treatment effectiveness and reduce side effects in people with low vitamin D levels. **You may be eligible if...** - You are between 18 and 80 years old - You have been newly diagnosed with breast cancer confirmed by biopsy - Your vitamin D blood level is below 20 ng/mL - You are planning to receive at least 4 cycles of chemotherapy before surgery - Your general health is adequate (ECOG 0-2) **You may NOT be eligible if...** - You have had prior chemotherapy for breast cancer - You are allergic to vitamin D or calcium - You have conditions affecting vitamin D or bone health - You have taken vitamin D or calcium supplements in the past 3 months - You have other cancers - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant therapy + vitamin D2

Before the start of treatment and every 3 weeks thereafter, participants will receive injections of vitamin D2 at a dosage of 10 mg until the completion of neoadjuvant therapy. They will undergo the standard neoadjuvant regimen, which includes the 10 mg injection of vitamin D2 per cycle during the therapy. The dosage of neoadjuvant drugs may be tailored based on the physician's clinical judgment.

DRUGNeoadjuvant therapy

Participants will receive the standard neoadjuvant regimen during each cycle of neoadjuvant therapy. The dosage of the neoadjuvant drugs may be tailored based on the physician's clinical judgment.

Locations(2)

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Qinghai University Affiliated Hospital

Xining, Qinghai, China

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NCT06642428

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