Study of Vitamin D Supplementation Effects on Neoadjuvant Therapy Outcomes and Side Effects in Breast Cancer Patients

What this Trial Is About

Researchers are evaluating the impact of supplemental vitamin D on the effectiveness and side effects of neoadjuvant therapy in patients with breast cancer. This randomized controlled Phase III trial aims to compare outcomes such as response rates and adverse effects between patients receiving standard therapy with or without added vitamin D. The study focuses on patients whose breast cancer is confirmed and who have low vitamin D levels before starting treatment. Participants are randomly assigned to one of two groups. One group receives standard neoadjuvant therapy plus vitamin D2 injections of 10 mg every three weeks throughout their treatment cycles. The other group receives only the standard neoadjuvant therapy, with dosages adjusted by their physician as needed. Both groups undergo treatment cycles approximately every three weeks until completion. Throughout the study, blood samples and imaging are collected before treatment and after every two therapy cycles to assess response. Researchers measure key outcomes including the objective response rate, pathological complete response rate, disease control rate, and significant adverse effects related to therapy. Side effects are monitored from treatment start until 21 days after the last therapy cycle. The total study duration for each participant spans about 4 to 6 months, allowing thorough evaluation of treatment impact and safety.

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