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Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06642441•Jiuda Zhao

View on ClinicalTrials.gov

Summary

This randomized controlled Phase III trial was designed to evaluate the effect of vitamin D supplementation (VD) on chemotherapy side effects following adjuvant chemotherapy in breast cancer

Detailed Description

This is a parallel group, open-label randomized controlled trial to investigate the occurrence of side effects of vitamin D supplementation (VD) in adjuvant chemotherapy in patients with breast cancer. Both groups will receive standard adjuvant chemotherapy on day 1 and each subsequent cycle. In addition, vitamin D2 will be given randomly to both groups. Blood samples and imaging results were collected and analyzed before initiation of adjuvant chemotherapy and after every two cycles. The primary outcome to be documented was associated grade III or higher adverse events during adjuvant chemotherapy. Primary and secondary study findings and adverse events will be thoroughly evaluated.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Key Dates

Start Date

December 1, 2024

Primary Completion Date

January 31, 2026

Completion Date

April 30, 2026

Last Updated

January 17, 2025

Enrollment

100

ESTIMATED participants

Conditions

Vitamin DChemotherapyBreast CancerAdverse Reaction

Interventions

Chemotherapy + vitamin D2

DRUG

Chemotherapy

DRUG

Contacts

Jiuda Zhao

CONTACT

869716230893 jiudazhao@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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