RecruitingNot ApplicableNCT06642441

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


Sponsor

Jiuda Zhao

Enrollment

100 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether vitamin D supplements can reduce the side effects of adjuvant chemotherapy (chemotherapy given after surgery) in breast cancer patients with low vitamin D levels. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with breast cancer confirmed by biopsy - Your vitamin D blood level is below 20 ng/mL - You are scheduled to receive at least 4 cycles of adjuvant chemotherapy after surgery - Your general health is adequate (ECOG 0-2) **You may NOT be eligible if...** - You have had prior chemotherapy for breast cancer - You are allergic to vitamin D or calcium - You have conditions affecting vitamin D or bone health - You have taken vitamin D or calcium supplements in the past 3 months - You have other cancers - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChemotherapy + 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.

DRUGChemotherapy

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.


Locations(2)

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Qinghai University Affiliated Hospital

Xining, Qinghai, China

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NCT06642441


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