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Search / Trial NCT06642441

Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer

Launched by JIUDA ZHAO · Oct 13, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Vitamin D Breast Cancer Adverse Reaction

ClinConnect Summary

This clinical trial is studying whether taking vitamin D supplements can help reduce the side effects of chemotherapy for people with breast cancer who are starting treatment. Researchers want to see if patients who have low vitamin D levels (less than 20 ng/ml) will feel better during and after their chemotherapy sessions when they take vitamin D. The trial is currently looking for participants aged 18 to 80 who are about to begin at least four cycles of chemotherapy and have not received chemotherapy before.

To be eligible, participants should have a confirmed diagnosis of breast cancer and be in generally good health, with no significant other health issues. They will need to agree to sign a consent form to take part in the study. If you join, you can expect regular check-ins and tests to monitor how well the vitamin D is working and how you are feeling throughout your treatment. This trial is important because it could provide valuable information on how to make chemotherapy more manageable for breast cancer patients.

Gender

ALL

Eligibility criteria

  • 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 pathological examination.
  • 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 at least 4 cycles of
  • 5. Patients with adjuvant 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 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.

About Jiuda Zhao

Jiuda Zhao is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive expertise in clinical development and regulatory affairs, Jiuda Zhao leads initiatives that focus on innovative therapeutic solutions across various therapeutic areas. The organization is driven by a passion for scientific excellence and collaboration, ensuring that clinical trials are conducted with the highest standards of integrity, safety, and ethical compliance. Through strategic partnerships and a patient-centric approach, Jiuda Zhao aims to facilitate the successful translation of research discoveries into effective treatments.

Locations

Xining, Qinghai, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported