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

Last updated: January 16, 2025
Sponsor: Jiuda Zhao
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chemotherapy

Cancer

Breast Cancer

Treatment

Neoadjuvant therapy

Neoadjuvant therapy + vitamin D2

Clinical Study ID

NCT06642428
AHQU-2024003
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

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 pathologicalexamination.

  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 atleast 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

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.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Neoadjuvant therapy
Phase:
Study Start date:
October 18, 2024
Estimated Completion Date:
April 30, 2026

Study Description

This is a parallel-group, open-label randomized controlled trial designed to investigate the effects of supplemental vitamin D (VD) on the outcomes and side effects of neoadjuvant therapy in patients with breast cancer. Both groups will receive standard neoadjuvant therapy on day 1 and for each subsequent cycle. Additionally, vitamin D2 will be randomly administered to both groups.Blood samples and imaging results will be collected and analyzed prior to the initiation of neoadjuvant therapy and after every two cycles. Key outcomes to be recorded include the pathological complete response rate (pCR), objective response rate (ORR), disease control rate (DCR), and grade III or higher adverse effects related to neoadjuvant therapy. The primary and secondary study findings, along with adverse events, will be thoroughly evaluated.

Connect with a study center

  • Qinghai University Affiliated Hospital

    Xining, Qinghai 810000
    China

    Site Not Available

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