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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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.

• 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.

Locations
Other Locations
China
Qinghai University Affiliated Hospital
RECRUITING
Xining
Qinghai University Affiliated Hospital
NOT_YET_RECRUITING
Xining
Contact Information
Primary
Jiuda Zhao
jiudazhao@126.com
869716230893
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 140
Treatments
Experimental: Neoadjuvant 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.
Other: Neoadjuvant 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.
Related Therapeutic Areas
Sponsors
Leads: Jiuda Zhao

This content was sourced from clinicaltrials.gov

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