Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJiuda Zhao
About this trial
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 criteria
Qualifiers
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 5.neoadjuvant chemotherapy or combined targeted therapy.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Neoadjuvant therapy + vitamin D2
- Neoadjuvant therapy
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jiuda Zhao
Lead sponsor
Affiliated Hospital of Qinghai University
Sponsor institution
Source ClinicalTrials.gov