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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Vitamin D Chemotherapy Breast Cancer Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy + vitamin D2

Before the start of treatment and every 3 weeks thereafter, participants will receive a 10-milligram dose of vitamin D2 injection until adjuvant chemotherapy is completed. They will receive a standard adjuvant chemotherapy regimen, which includes 10 mg of vitamin D2 injections per cycle during treatment. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.

Group Type EXPERIMENTAL

Chemotherapy + vitamin D2

Intervention Type DRUG

Before the start of treatment and every 3 weeks thereafter, participants will receive a 10 mg dose of vitamin D2 injection until adjuvant chemotherapy is completed. They will receive a standard adjuvant chemotherapy regimen, which includes 10 mg of vitamin D2 injections per cycle during treatment. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.

chemotherapy

Participants will receive a standard adjuvant chemotherapy regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.

Group Type OTHER

Chemotherapy

Intervention Type DRUG

Participants will receive a standard adjuvant chemotherapy treatment regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.

Interventions

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Chemotherapy + vitamin D2

Before the start of treatment and every 3 weeks thereafter, participants will receive a 10 mg dose of vitamin D2 injection until adjuvant chemotherapy is completed. They will receive a standard adjuvant chemotherapy regimen, which includes 10 mg of vitamin D2 injections per cycle during treatment. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.

Intervention Type DRUG

Chemotherapy

Participants will receive a standard adjuvant chemotherapy treatment regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No